Data catalog

Emergency Use Authorizations

About 891 records

All records

Every EUA record published by Orca1, 1000 per page. Each page lists the record id and its name; open a record for key facts, related records and what Orca1 adds.

  1. Genabio COVID-19 Rapid Self-Test Kit
  2. Apollo ABVM
  3. CP101/CP101S Series
  4. CRL Rapid Response
  5. BioCore 2019-nCoV Real Time PCR Kit
  6. PhoenixDx 2019-CoV
  7. Sidra Surgical Face Mask AD3PL2WH
  8. Zika Virus RNA Qualitative Real-Time RT-PCR (Quest Diagnostics Infectious Disease, Inc.)
  9. Accula SARS-Cov-2 Test
  10. WELLlife COVID-19 / Influenza A&B Home Test
  11. Synapse Biomedical, Inc. TransAeris Diaphragmatic Pacing Therapy System (DPTS)
  12. Stellar 150 (Amended September 1, 2020)
  13. PortPatch
  14. 03d99402-76e5-d140-6f7d-f858b1a9ad7a
  15. BD Respiratory Viral Panel for BD MAX System
  16. BioCheck SARS-CoV-2 IgM Antibody Test Kit
  17. CDC Zika Immunoglobulin M (IgM) Antibody Capture Enzyme-Linked Immunosorbent Assay
  18. Dimar CPAP Helmet
  19. Lucira by Pfizer COVID-19 & Flu Test
  20. Diversified Medical Healthcare SARS-CoV-2 Assay
  21. LumiraDx SARS-CoV-2 RNA STAR Complete
  22. ACON SARS-CoV-2 IgG/IgM Rapid Test
  23. DAR Adult Dual Patient Breathing Circuit 301P14429
  24. SynergyDx SARS-CoV-2 RNA Test DTC
  25. SARS-CoV-2 Test Kit (Real-time PCR)
  26. Authorization
  27. D-Care Surgical Face Mask 3 ply (white), TAMMY Surgical Face Mask 3 ply (white)
  28. Quest COVID-19 PCR DTC
  29. Cormeum SARS-CoV-2 Assay
  30. STANDARD M nCoV Real-Time Detection Kit
  31. DxTerity SARS-CoV-2 RT-PCR Test
  32. Hi-Sense COVID-19 Molecular Testing Kit 1.0
  33. Allplex 2019-nCoV Assay
  34. IDS SARS-CoV-2 IgG
  35. Life 2000 Ventilation System Product No. BT-V5
  36. UCSD EXCITE COVID-19 EL Test
  37. OSOM Flu SARS-CoV-2 Combo Test
  38. NIOSH-Approved Air Purifying Respirators for Use in Health Care Settings During Response…
  39. Azure FaStep® COVID-19 Antigen Pen Home Test
  40. ViraDx SARS-CoV-2/Flu A+B Rapid Antigen Test
  41. ImmuView COVID-19 Antigen Home Test
  42. The Single Path Airway Rapid Retrofit Optional Workflow ("Sparrow") COVID-19 Co-Ventilator…
  43. PRECISION ECO™ Compostable / Plant Based Procedural Mask with Earloops (black - 100195…
  44. AQ-TOP COVID-19 Rapid Detection Kit
  45. InteliSwab COVID-19 Rapid Test
  46. Labcorp Seasonal Respiratory Virus RT-PCR DTC Test
  47. ZIKV Detect 2.0 IgM Capture ELISA (InBios International, Inc.)
  48. Northwell 3D Printed BiPAP Adapter
  49. InteliSwab COVID-19 Rapid Test
  50. BinaxNOW COVID-19 Ag Card
  51. PMLS SARS-CoV-2 Assay
  52. Lyra SARS-CoV-2 Assay
  53. BioCode SARS-CoV-2 Assay
  54. Spiro Wave (Amended June 8, 2020)
  55. Zika Virus Real-time RT-PCR Test (Viracor Eurofins)
  56. REGEN-COV (Casirivimab and Imdevimab)
  57. TaqPath COVID-19 Fast PCR Combo Kit 2.0
  58. Lyra x1 and Lyra x2 Ventilators
  59. WELLlife COVID-19 / Influenza A&B Home Test
  60. LightMix Zika rRT-PCR Test (Roche Molecular Systems, Inc.)
  61. Xpert Xpress CoV-2 plus
  62. Psoma COVID-19 RT Test
  63. Lumis 150 VPAP ST (Amended April 17, 2020)
  64. SARS-CoV-2 Fluorescent PCR Kit
  65. LIAISON SARS-CoV-2 TrimericS IgG
  66. ECL COVID TEST SYSTEM
  67. WELLlife COVID-19 / Influenza A&B Test
  68. BayCare SARS-CoV-2 RT PCR Assay
  69. Nano-Check Influenza+COVID-19 Dual Test
  70. Fulgent COVID-19 by RT-PCR Test
  71. MICo Medical CoroVent
  72. 1copy COVID-19 qPCR Multi Kit
  73. Flowflex COVID-19 Antigen Rapid Test
  74. Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
  75. Baxter Healthcare Corporation, Prismaflex ST Set
  76. GGM Respiratory Humidifier, Models VH-2100, VH2600A, and VH-2600
  77. OMNIgene·ORAL OM-505 and OME-505 (OMNIgene·ORAL) saliva collection devices
  78. Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody Test
  79. Genetrack SARS-CoV-2 Molecular Assay
  80. iHealth COVID-19/Flu A&B Rapid Test
  81. ARCH MedTech Level 3 Surgical Mask - AMT-001L (Earloop)
  82. NeuMoDx SARS-CoV-2 Assay
  83. ADVIA Centaur Zika test (Siemens Healthcare Diagnostics Inc.)
  84. Color SARS-CoV-2 RT-LAMP Diagnostic Assay
  85. Everlywell COVID-19 & Flu Test Home Collection Kit
  86. O2FLO High Flow Respiratory Humidifier (VUN-001)
  87. Alinity m SARS-CoV-2 assay
  88. Labcorp Seasonal Respiratory Virus RT-PCR Test
  89. Janssen COVID-19 Vaccine
  90. SCoV-2 Detect IgG ELISA
  91. BD Veritor System for Rapid Detection of SARS-CoV-2
  92. Q-Plex SARS-CoV-2 Human IgG (4 Plex)
  93. Lungpacer Medical, Inc. Diaphragm Pacing Therapy System (DPTS)
  94. Metrix COVID-19 Test
  95. Hoplon Brand Disposable Single Use Surgical Masks Level 1 per ASTM F2100 H3SS
  96. CDC Novel Coronavirus 2012 Real-time RT-PCR Assay
  97. Intersurgical StarMed CaStar R Hood for NIV
  98. Gnomegen COVID-19 RT-Digital PCR Detection Kit
  99. Authorization
  100. Sherlock CRISPR SARS-CoV-2 Kit
  101. Baxter Healthcare Corporation, Prismaflex HF20 Set
  102. IntelliVue Patient Monitors, Philips Medizin Systeme Boeblingen GmbH
  103. 1e3e0eea-5de8-e6c2-8a36-27b1fe4a441b
  104. Assure COVID-19 IgG/IgM Rapid Test Device
  105. Panther Fusion SARS-CoV-2 Assay
  106. CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test
  107. Visby Medical Respiratory Health Test
  108. Sotrovimab
  109. BD SARS-CoV-2 Reagents for BD MAX System
  110. Negative-pressure Respiratory System with Advanced Ventilation Return (NRSAVR-100)
  111. UDX SARS-CoV-2 Molecular Assay
  112. MassARRAY SARS-CoV-2 Panel
  113. The Nano Test for COVID-19
  114. Resware BI 20 S, Resware BI Auto S, Resware BI 25 S/T, Resware BI 30 S/T, ZiZ Auto, Aurora…
  115. 3 Ply Surgical Mask (Model # 62212)
  116. Quest RC COVID-19 PCR DTC
  117. REGIOCIT replacement solution that contains citrate for regional citrate anticoagulation…
  118. Aptima Zika Virus assay (Hologic, Inc.)
  119. ViroKey SARS-CoV-2 RT-PCR Test v2.0
  120. Kroger Health COVID-19 Test Home Collection Kit
  121. VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Reagent Pack used in…
  122. Liberate Medical, LLC VentFree Respiratory Muscle Stimulator Device
  123. In-Dx SARS-CoV-2 RT-LAMP Assay
  124. Everlywell COVID-19 Test Home Collection Kit DTC
  125. OPTI SARS-CoV-2 RT PCR Test
  126. 252ac8ad-9d53-52f0-519a-137487d20127
  127. Bio-Rad SARS-CoV-2 ddPCR Test
  128. O2U Ventilator: Model 100
  129. iHealth COVID-19 Antigen Rapid Test Pro
  130. SARS-CoV-2 Assay
  131. EmpowerDX COVID-19 Home Collection Kit DTC
  132. cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System (cobas SARS-CoV-2)
  133. GS COVID-19 RT-PCR KIT
  134. Oral formulations of doxycycline products for the post-exposure prophylaxis (PEP) of…
  135. Orig3n 2019 Novel Coronavirus (COVID-19) Test
  136. Biomeme SARS-CoV-2 Real-Time RT-PCR Test
  137. Celltrion DiaTrust COVID-19 Ag Home Test
  138. Healgen COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab)
  139. Ezplex SARS-CoV-2 G Kit
  140. FTD SARS-CoV-2
  141. WorldVent Ventilator
  142. CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test
  143. INDICAID COVID-19 Rapid Antigen Test
  144. SARS-CoV-2 RT-PCR Assay
  145. SCoV-2 Ag Detect Rapid Self-Test
  146. ADVIA Centaur SARS-CoV-2 IgG (sCOVG)
  147. InteliSwab COVID-19 Rapid Test
  148. GENETWORx Covid-19 Nasal Swab Test
  149. Elecsys IL-6
  150. P23 Labs TaqPath SARS-CoV-2 Assay
  151. STANDARD Q COVID-19 Ag Test 2.0
  152. Authorization
  153. Chloroquine phosphate and hydroxychloroquine sulfate for treatment of COVID-19
  154. Abbott RealTi
  155. CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel-Influenza A/H7 (Eurasian…
  156. Amendment to the Letter of Authorization (October 14, 2011)
  157. ORAcollect∙RNA OR-100 and ORAcollect∙RNA ORE-100 saliva collection devices
  158. CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test
  159. Lucira COVID-19 All-In-One Test Kit
  160. QuickVue At-Home COVID-19 Test
  161. Quaeris SARS-CoV-2 Assay
  162. iC SARS-CoV2 Test
  163. Anumana Inc, ELEFT
  164. COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)
  165. Procedure Mask with Earloops (PM345 E)
  166. MobileDetect Bio BCC19 (MD-Bio BCC19) Test Kit
  167. Fresenius Medical, multiFiltrate PRO System and multiBic/multiPlus Solutions
  168. Premier Guard USA Surgical Face Mask 20-1002-SFM3
  169. PZero Surgical Mask Model Number: FM20PZ00
  170. COVID-19 Key
  171. Rapid SARS-CoV-2 Antigen Test Card
  172. Safe Flight 9100-3 Quad Vent
  173. Color SARS-CoV-2 RT-LAMP Diagnostic Assay
  174. TaqPath COVID-19, FluA, FluB Combo Kit
  175. The Nano Test for COVID-19
  176. 3PLY Surgical Mask KF-SM3-EL
  177. YUWELL®
  178. iHealth COVID-19/Flu A&B Rapid Test Pro
  179. COV-19 IDx assay
  180. Clear Dx SARS-CoV-2 Test
  181. Ecotest COVID-19 IgG/IgM Rapid Test Device
  182. CareStart COVID-19 MDx RT-PCR
  183. SleepWeaver Prevent Mask
  184. Jynneos
  185. Lucira CHECK-IT COVID-19 Test Kit
  186. GenBody COVID-19 Ag
  187. Phosphorous COVID19 RT-qPCR Test DTC
  188. SalivaDirect At-Home Collection Kit
  189. Quest COVID-19 Nucleic Acid Test Collection Kit
  190. SARS-CoV-2 Assay
  191. Helix COVID-19 NGS Test
  192. ViraDx SARS-CoV-2/Flu A+B Rapid Antigen Test
  193. octaplas LGPowder (Octapharma Pharmazeutika Produktionsges.m.b.H.)
  194. Pinpoint by Phosphorus COVID-19 Test Home Collection Kit DTC
  195. Nano-Check Influenza+COVID-19 Dual Test
  196. Pathogen-Reduced Leukocyte-Depleted Freeze Dried Plasma (Centre de Transfusion Sanguine…
  197. QUANTA Flash SARS-CoV-2 IgG
  198. Filtra Systems Surgical Face Mask (Model number - 0605202)
  199. 3 Ply Surgical Mask (Model #62222)
  200. LumiraDx SARS-CoV-2 RNA STAR
  201. LA Series Ventilators LA20C, LA20A, LA20B, LA20B, LA25B, LA25B
  202. SalivaDirect
  203. TaqPath COVID-19 RNase P Combo Kit 2.0
  204. InspectIR COVID-19 Breathalyzer
  205. 3EO Health COVID-19 Test
  206. 3B Hi-Flow H80
  207. BioFire COVID-19 Test
  208. Speedy Swab Rapid COVID-19 Antigen Self-Test
  209. Solana SARS-CoV-2 Assay
  210. CLINITEST Rapid COVID-19 Antigen Self-Test
  211. Clarifi COVID-19 Test Kit
  212. EZ1 Real-time RT-PCR Assay
  213. The AscencioDx COVID-19 Test and The AscencioDx Molecular Detector
  214. COVID-19 convalescent plasma
  215. Procedure Mask with Earloops (PM345 D)
  216. Color SARS-CoV-2 RT-LAMP Diagnostic Assay DTC
  217. OraQuick Ebola Rapid Antigen Test - for use with whole blood (OraSure Technologies, Inc.)
  218. ADVIA Centaur IL6 assay
  219. IntelliPlex SARS-CoV-2 Detection Kit
  220. Acupath COVID-19 Real-Time (RT-PCR) Assay
  221. Clinomics TrioDx RT-PCR COVID-19 Test
  222. Authorization
  223. Surgical Mask (Model - MAC-6501)
  224. TekiTrust COVID-19 IgG
  225. JIXI H-100
  226. ALPHADx SARS-COV-2 RT-PCR Test
  227. COVID-19 Self-Collected Antibody Test System
  228. COVID-19 ELISA IgG Antibody Test
  229. LUISA Life Support Ventilator LM150TD
  230. Face Shields
  231. CDI Enhanced COVID-19 Test
  232. OSOM COVID-19 Antigen Home Test
  233. Logix Smart Coronavirus Disease 2019 (COVID-19) Kit
  234. Surgical Mask, Model Number - 2130
  235. MOCACARE Procedure Mask (Level 1)
  236. Revogene SARS-CoV-2
  237. SuppleVent
  238. ID NOW COVID-19
  239. OHC COVID-19 Antigen Self Test
  240. Medtecs Medical Mask (Model FM-140G)
  241. DxLab COVID-19 Test
  242. OSOM Flu SARS-CoV-2 Combo Test
  243. 3 Ply Surgical Mask
  244. Novel Coronavirus (SARS-CoV-2) Fast Nucleic Acid Detection Kit (PCR-Fluorescence Probing)
  245. ExProbe SARS-CoV-2 Testing Kit
  246. SalivaDirect for use with DTC Kits
  247. Zika Virus Detection by RT-PCR Test (ARUP Laboratories)
  248. Airway Dome
  249. BinaxNOW COVID-19 Ag Card Home Test
  250. Authorization
  251. VORTRAN GO2VENT with PEEP Valve
  252. COVID Ventor
  253. MAWD Laboratories SARS-CoV-2 Dual Target by RT-PCR
  254. Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay
  255. RealStar MERS-CoV RT-PCR Kit U.S.
  256. BioFire Respiratory Panel 2.1-EZ (RP2.1-EZ)
  257. OSOM Flu SARS-CoV-2 Combo Test
  258. Abiomed, Inc., Impella RP System
  259. BioCheck SARS-CoV-2 IgG and IgM Combo Test
  260. Transcend 3 BiPAP
  261. SafeSource Direct Surgical Mask with Ear Loops (Model EUA3001)
  262. QIAreach SARS-CoV-2 Antigen
  263. ePlex Respiratory Pathogen Panel 2
  264. 2011 Letter of Authorization
  265. Abbott RealTime SARS-CoV-2 assay
  266. WELLlife COVID-19 / Influenza A&B Test
  267. VitalConnect, Inc., VitalPatch
  268. Authorization
  269. ECL COVID TEST SYSTEM-1
  270. Virgin Orbit Resuscitator (Amended
  271. OraRisk COVID-19 RT-PCR
  272. Viracor SARS-CoV-2 assay
  273. CareStart
  274. Authorization
  275. Quest Diagnostics RC SARS-CoV-2 Assay
  276. WELLlife COVID-19 / Influenza A&B Test
  277. SARS-CoV-2 Assay
  278. DASH SARS-CoV-2/S Test
  279. SalivaDirect At-Home Collection Kit
  280. Venus Medical Grade Disposable Surgical Mask
  281. Gravity Diagnostics SARS-CoV-2 RT-PCR Assay
  282. G Medical Innovations, Ltd., VSMS Patch
  283. IntelliPAP/SleepCube Model DV56 ST Series Bilevel
  284. SARS-CoV-2 MassArray Test
  285. SalivaDirect
  286. TaqPath COVID-19 Combo Kit
  287. ViroKey SARS-CoV-2 RT-PCR Test
  288. SynergyDx SARS-CoV-2 RNA Test
  289. LetsGetChecked Coronavirus (COVID-19) Test
  290. Mount Sinai SARS-CoV-2 Assay
  291. Quest SARS-CoV-2 rRT-PCR
  292. AMPIPROBE SARS-CoV-2 Test System
  293. Sesa Health Surgical Mask (Model Number - SH.PPE.SM.2L3)
  294. CareStart EZ COVID-19 IgM/IgG
  295. ID NOW COVID-19 2.0
  296. SARS-CoV-2 PCR test
  297. CorDx TyFast Flu A/B & COVID-19 At Home Multiplex Rapid Test
  298. Nomad Surgical Mask N-MASK-3
  299. WELLlife COVID-19 / Influenza A&B Home Test
  300. SCoV-2 Detect IgG Rapid Test
  301. Labcorp SARS-CoV-2 & Influenza A/B Assay
  302. iBreeze PAP
  303. EUROIMMUN Anti-SARS-CoV-2 S1 Curve ELISA (IgG)
  304. Luna G3 BPAP S/T- LG3800-G3 B30VT
  305. Lyra Direct SARS-CoV-2 Assay
  306. Lucira by Pfizer COVID-19 & Flu Home Test
  307. Authorization
  308. BD MAX COVID-19 ASSAY (Authorized by HHS/OASH)
  309. Wheeler Labs COVID-19 RT-qPCR Test
  310. Metrix COVID-19 Test
  311. ISOCUBE SS and ISOCUBE ONE
  312. Elecsys Anti-SARS-CoV-2 S
  313. New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel
  314. Y-30T
  315. SalivaDirect DTC Saliva Collection Kit
  316. Pixel by LabCorp COVID-19 Test Home Collection Kit
  317. Venti-Now Resuscitator
  318. BinaxNOW COVID-19 Antigen Self Test
  319. BIOTIME SARS-CoV-2 IgG/IgM Rapid Qualitative Test
  320. SDI SARS-CoV-2 Assay
  321. Celltrion DiaTrust COVID-19 Ag Rapid Test
  322. Puritan Bennet Reusable Pediatric-Adult Expiratory Filter
  323. Hypnus ST730
  324. WREN Laboratories COVID-19 PCR Test
  325. Access IL-6
  326. Solaris Multiplex SARS-CoV-2 Assay
  327. DetectX-Rv
  328. AvellinoCoV2 test
  329. Lilly SARS-CoV-2 Assay
  330. SARS-CoV-2 Real-Time RT-PCR-Test
  331. VITAL ventilator
  332. Speedy Swab Rapid COVID-19 + Flu A&B Antigen Test
  333. Sesa Health Surgical Mask (Model Number - SH.PPE.SM.2L3)
  334. Genabio COVID-19 Rapid Self-Test Kit
  335. BU SARS-CoV-2 Test
  336. Safe Flight 9100-1 Quad Vent
  337. Bamlanivimab and Etesevimab
  338. SARS-CoV-2 RT-PCR test
  339. KNH Surgical Face Mask
  340. ARIES SARS-CoV-2 Assay
  341. AdvanSure SARS-CoV-2 IgG(S1) ELISA
  342. Color COVID-19 Self-Swab Collection Kit
  343. InteliSwab COVID-19 Rapid Test Pro
  344. Nomad Surgical Mask N-MASK-3
  345. Luna G3 B30VT
  346. Gx HTIQ SARS-CoV-2 Test
  347. 63b9b89f-77df-7b63-6dd1-cce8f6322484
  348. MediVent ICU- MCV
  349. Atropine Auto-Injector (Rafa Laboratories Ltd.)
  350. UMass Molecular Virology Laboratory 2019-nCoV rRT-PCR Dx Panel
  351. Cuur Diagnostics SARS-CoV-2 Molecular Assay
  352. Global Direct RT-PCR Test
  353. MAGLUMI 2019-nCoV IgM/IgG
  354. Aeon Global Health SARS-CoV-2 Assay
  355. Quest Diagnostics HA SARS-CoV-2 Assay
  356. On/Go One COVID-19 Antigen Home Test
  357. cobas SARS-CoV-2 & Influenza A/B
  358. Sienna COVID-19 Antigen Rapid Test Cassette
  359. CPAP Devices: DM28-20C-G;
  360. Clinical Enterprise SARS-SoV-2-RT-PCR Assay
  361. LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold)
  362. MaximBio ClearDetect COVID-19 Antigen Home Test
  363. ALung Technologies, Inc., Hemolung RAS
  364. DxTerity SARS-CoV-2 RT PCR CE Test
  365. COVID-19 Nucleic Acid RT-PCR Test Kit
  366. DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit
  367. CareStart COVID-19 Antigen test
  368. Clinical Enterprise SARS-CoV-2 RT-PCR Assay
  369. COVID-19 Airway Management Isolation Chamber (CAMIC)
  370. GA ST
  371. Quest Diagnostics RC COVID-19+Flu RT-PCR
  372. Advin COVID-19 Antigen Test @Home
  373. CytoSorbents, Inc. Extracorporeal Blood Purification (EBP) Device
  374. Beijing Aeonmed Shangrila510S
  375. Outdoor Research Surgical Mask model #OR2159
  376. V+Pro Emergency Ventilator
  377. COVID-SeroKlir, Kantaro Semi-Quantitative SARS-CoV-2 IgG Antibody Kit
  378. Babylog VN800 and VN600
  379. RapCov Rapid COVID-19 Test
  380. Abiomed, Inc., Impella LV Systems
  381. QuickFinder COVID-19 Antigen Self Test
  382. YUWELL YH-725 BiPAP
  383. Vault Health COVID-19 Test
  384. Procedure Mask with Earloops
  385. MDT Medical Products 3PLY Mask
  386. GK ACCU-RIGHT SARS-CoV-2 RT-PCR KIT
  387. Fosun COVID-19 RT-PCR Detection Kit
  388. Fabius Plus / Fabius Plus XL
  389. CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test
  390. Stellar 150 (Amended September 1, 2020)
  391. Sofia 2 Flu + SARS Antigen FIA
  392. cobas SARS-CoV-2
  393. OSOM Flu SARS-CoV-2 Combo Home Test
  394. B. Braun Space and Outlook Pumps
  395. Sharp MQ-3050 Surgical mask; Foxconn MQ-3050 Surgical mask
  396. Warrior Diagnostics SARS-CoV-2 Assay
  397. ellume.lab COVID Antigen Test
  398. Authorization
  399. RealStar SARS-CoV02 RT-PCR Kits U.S.
  400. Clear Dx SARS-CoV-2 WGS v3.0 Test
  401. CirrusDx SARS-CoV-2 Assay
  402. TaqPath Zika Virus Kit (Thermo Fisher Scientific)
  403. WPT ASTM F2100-19 Level 3 Earloop Surgical Face Mask (Model # SMS2020)
  404. Tiger Tech Solutions, Inc., Tiger Tech COVID Plus Monitor
  405. COVIAGE
  406. Elecsys Anti-SARS-CoV-2
  407. Bio-Speedy Direct RT-qPCR SARS-CoV-2
  408. BioCheck SARS-CoV-2 IgG Antibody Test Kit
  409. Gnomegen COVID-19-RT-qPCR Detection Kit
  410. MedArbor Diagnostics SARS-CoV-2 Assay
  411. VentSplitter Emergency Ventilator Circuit Splitter and Flow Limiters
  412. QDX SARS-CoV-2 Assay
  413. QuantiVirus SARS-CoV-2 Test kit
  414. Quest COVID-19 PCR Test Home Collection Kit
  415. Oral formulations of doxycycline products for the post-exposure prophylaxis (PEP) of…
  416. CVBS Surgical Mask - Model Number: SM1
  417. KarmaCare COVID-19 MDx RT-PCR
  418. Life Sciences Testing Center COVID-19 Test
  419. RapidRona Self-Collection Kit
  420. Diazyme DZ-Lite SARS-CoV-2 IgG CLIA Kit
  421. AQ-TOP COVID-19 Rapid Detection Kit PLUS
  422. LM Surgical Mask Level 3
  423. Quidel Lyra Influenza A Subtype H7N9 Assay
  424. Patient Isolation Transport Unit (PITU) Device
  425. PacificDx Covid-19
  426. Hanes Surgical Mask 01, Small and Large
  427. U-TOP COVID-19 Detection Kit
  428. Formlabs 3D Printed BiPAP Adapter
  429. Janisys CPAP Flow Generator
  430. Breathing Circuit Filter
  431. Rapid COVID-19 IgM/IgG Combo Test Kit
  432. Gene By Gene SARS-CoV-2 Detection Test
  433. Heat and Moisture Exchanging Filters (HMEF): HMEF 1000 Straight (Model 504-011, part…
  434. CorDx TyFast Flu A/B & COVID-19 At Home Multiplex Rapid Test
  435. SalivaNow SARS-CoV-2 Assay
  436. Ventway Sparrow
  437. Metrix COVID/Flu Test
  438. Healthcare Pro Surgical Masks
  439. FilmArray Biothreat-E test
  440. ADEXUSDx COVID-19 Test
  441. Avera Institute for Human Genetics SARS-CoV-2 Assay
  442. ExThera Medical Corporation Extracorporeal Blood Purification (EBP) Device
  443. Mahe Medical Disposable Surgical Face Mask with Earloops, Model 001-USA-E
  444. Procleix SARS-CoV-2 Assay
  445. High Flow Humidifier (HFT-150)
  446. SalivaDirect for use with DTC Kits
  447. Clinical Enterprise SARS-CoV-2 RT-PCR Assay DTC
  448. Speedy Swab Rapid COVID-19 + Flu A&B Antigen Self-Test
  449. Flow Control Valve
  450. ReddyPort Mini NIV Access Elbow
  451. Antivirals
  452. CorDx TyFast Flu A/B & COVID-19 At Home Multiplex Rapid
  453. DTPM COVID-19 RT-PCR Test
  454. 3-ply level 3 Earloop - LM0787
  455. Scope Molecular Laboratory SARS nCoV-2019 Multiplexed Assay
  456. UCLA SwabSeq COVID-19 Diagnostic Platform
  457. WANTAI SARS-CoV-2 Ab ELISA
  458. WELLlife COVID-19 / Influenza A&B Test
  459. Sofia SARS Antigen FIA
  460. EliA SARS-CoV-2-Sp1 IgG Test
  461. Primerdesign Ltd COVID-19 genesig Real-Time PCR assay
  462. Dimension Vista SARS-CoV-2 Total antibody assay (COV2T)
  463. Amazon Real-Time RT-PCR Test for Detecting SARS-CoV-2
  464. Diazyme DZ-Lite SARS-CoV-2 IgM CLIA Kit
  465. Everlywell COVID-19 Test Home Collection Kit
  466. CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel (CDC)
  467. Aptima SARS-CoV-2/Flu assay
  468. iHealth COVID-19/Flu A&B Rapid Test
  469. iHealth COVID-19/Flu A&B Rapid Test Pro
  470. BioeXsen SARS-CoV-2 RT PCR
  471. iHealth COVID-19/Flu A&B Rapid Test Pro
  472. CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test
  473. Coventor Adult Manual Resuscitator Compressor
  474. AirLife DuoTherm Humidification System
  475. Ventilator Sharing and Monitoring
  476. Platelia SARS-CoV-2 Total Ab assay
  477. Access SARS-CoV-2 IgM
  478. Alimetrix SARS-CoV-2 RT-PCR Assay
  479. Flowflex Plus COVID-19 and Flu A/B Home Test
  480. Texas Department of State Health Services (DSHS) SARS-CoV-2 Assay
  481. Xpert Xpress CoV-2/Flu/RSV plus
  482. PhysiolGuard, ECG-QT Analysis System
  483. SARS-CoV-2 RBD IgG test
  484. Assurance SARS-CoV-2 Panel
  485. binx health At-Home Nasal Swab COVID-19 Sample Collection Kit
  486. AdultLife Pro Ventilator
  487. LIAISON SARS-CoV-2 Ag
  488. cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test
  489. OPTI SARS-CoV-2/ Influenza A/B RT-PCR Test (Version 1 and Version 2)
  490. Viracor SARS-CoV-2 assay
  491. iHealth COVID-19/Flu A&B Rapid Test
  492. Mechanical Ventilator Milano (MVM)
  493. QIAstat-Dx Respiratory SARS-CoV-2 Panel
  494. Respiratory SARS-CoV-2 RT-PCR Panel 1
  495. Evita V800 and Evita V600
  496. Vayu bubble Continuous Positive Airway Pressure Circuit ("Vayu bCPAP')
  497. Puritan Bennett 560 Ventilator System
  498. AdviseDx SARS-CoV-2 IgM
  499. Bio-Self COVID-19 Antigen Home Test
  500. binx/Assurance Covid-19 Collection Kit
  501. GeneFinder COVID-19 Plus RealAmp Kit
  502. Labcorp VirSeq SARS-CoV-2 NGS Test
  503. QuickVue SARS Antigen Test
  504. ASSURE-100 Rapid COVID-19 Test
  505. OHC COVID-19/Flu Antigen Test Pro
  506. CDC Novel Coronavirus 2012 Real-time RT-PCR Assay
  507. Humasis COVID-19 Ag Test
  508. Dimension EXL SARS-CoV-2 IgG (CV2G)
  509. WELLlife COVID-19 / Influenza A&B Home Test
  510. Personal Protective Equipment (PPE)
  511. Airborne Isolation Hood Device
  512. PMSF-INNO SARS-CoV-2 RT-PCR Test (Authorized by HHS/OASH)
  513. Flowflex Plus COVID-19 and Flu A/B Home Test
  514. Cue COVID-19 Test for Home and Over The Counter (OTC) Use
  515. Fixed Resistance Connector Valve
  516. LTV2 model 2200 and LTV model 2150
  517. 4 Ply Surgical Mast (Model #62232)
  518. Quick SARS-CoV-2rRT-PCR Kit
  519. 952f66d9-da72-8d84-bc5f-79e42360037d
  520. Xpert Ebola Assay
  521. Helix Diagnostics SARS nCoV-2019 Multiplexed Assay
  522. Dimension Vista SARS-CoV-2 IgG (COV2G)
  523. Predicine SARS-CoV-2 RT-PCR Test
  524. AustinP51
  525. SalivaDirect DTC Saliva Collection Kit
  526. Amplitude Solution with the TaqPath COVID-19 High-Throughput Combo Kit
  527. Disposable Surgical Mask BRNDX-DSM-001-LARGE
  528. Wilcox PATRIOT SAVR (Amended July 21, 2020)
  529. Genetron SARS-CoV-2 RNA Test
  530. MOCACARE Surgical Mask (Level 3)
  531. Access SARS-CoV-2 IgG II
  532. BreathDirect BDR-19
  533. MicroGEM Sal6830 SARS-CoV-2 Saliva Test
  534. Zika ELITe MGB Kit U.S. (ELITechGroup Inc. Molecular Diagnostics)
  535. SARS-CoV-2 Acutis Multiplex Assay
  536. BioCode CoV-2 Flu Plus Assay
  537. Disposable Single Use 4-Ply Earloop, model EcoGuard A ECO05
  538. 9a6cdbbb-11c6-0596-e43a-1e8366c24622
  539. LumiraDx SARS-CoV-2 Ag Test
  540. HealthPulse@home Fusion
  541. SKANRESPIRO/SKANRESPIRO PLUS
  542. INTAI SURGICAL MASK (non-sterile) - ASTM Level3
  543. Swab-N-Go Home Test COVID-19 Ag
  544. CII-ArboViroPlex rRT-PCR Assay (Columbia University)
  545. CaeAir1
  546. AerosolVE Device
  547. 9cb14265-6fd2-2297-1680-e35360f7e55e
  548. WANTAI SARS-CoV-2 Ab Rapid Test
  549. TRUPCR SARS-CoV-2 Kit
  550. QuickVue At-Home OTC COVID-19 Test
  551. High Flow Humidifier (HFT-150)
  552. Phosphorus COVID-19 RT-qPCR Test
  553. Fastep COVID-19 Antigen Home Test
  554. Lucira by Pfizer COVID-19 & Flu Test
  555. Dimar NIV Helmet
  556. Surgical Masks Model PLF.IIR
  557. Kaira 2019-nCoV Detection Kit
  558. LifeMech A-VS
  559. UBI SARS-CoV-2 ELISA
  560. Mindray SV300/SV600/SV800 ventilators
  561. UOL COVID-19 Test
  562. Helix COVID-19 Test
  563. Altru Dx SARS-CoV-2 RT-PCR assay
  564. CDC Ebola Virus NP Real-time RT-PCR Assay
  565. Letter of Authorization
  566. UCSD EXCITE COVID-19 Test
  567. BioGX Xfree COVID-19 Direct RT-PCR
  568. Procedure Mask with Earloops
  569. HealthPulse@home
  570. Apogee
  571. GGM Breathing Circuit Bacterial Filter; Models: VH-3110 (Model: Adult with luer port)…
  572. PEEP-Alert Pressure and Flow Monitor
  573. Sampinute COVID-19 Antigen MIA
  574. CDC Trioplex Real-time RT-PCR Assay (Trioplex rRT-PCR)
  575. Maverick SARS-CoV-2 Multi-Antigen Serology Panel v2
  576. Surgical Mask, Model Number - 2110
  577. BioFire COVID-19 Test
  578. VX850 Ventilator
  579. SARS-CoV-2 RNA DETECTR Assay
  580. SCoV-2 Detect IgM ELISA
  581. CDC Enterovirus D68 2014 Real-time RT-PCR Assay (EV-D68 2014 rRT-PCR)
  582. Status COVID-19 Antigen Rapid Test for Home Use
  583. Gene-RADAR Zika Virus Test (Nanobiosym Diagnostics, Inc.)
  584. CSI SARS-CoV-2 RT PCR Test
  585. Compass Laboratory Services SARS-CoV2 Assay
  586. Illumina COVIDSeq Test
  587. Nirmidas COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection Kit
  588. SDNA-1000 Saliva Collection Device
  589. PQM LibertyAir Surgical MaskModel - S-9501-EUA
  590. PhoenixDx SARS-CoV-2 Multiplex
  591. Status COVID-19/Flu A&B
  592. Boston Heart COVID-19 RT-PCR Test
  593. CorDx TyFast Flu A/B & COVID-19 At Home Multiplex Rapid Test
  594. SAVe II+ (M50016, M50017)
  595. Premier Biotech COVID-19 IgG/IgM Rapid Test Cassette
  596. Vibrant COVID-19 Ab Assay
  597. Heartland Health Surgical Mask
  598. T2SARS-CoV-2 Panel
  599. On/Go COVID-19 Antigen Self-Test
  600. Sienna-Clarity COVID-19 Antigen Rapid Test Cassette
  601. DPP Zika IgM Assay System (Chembio Diagnostic Systems, Inc.)
  602. VERSANT Zika RNA 1.0 Assay (kPCR) Kit (Siemens Healthcare Diagnostics Inc.)
  603. Surgical Mask - Disposable Single-Use 3-Ply Earloop
  604. MidaSpot COVID-19 Antibody Combo Detection Kit
  605. BEYOND C20A CPAP
  606. VentMI
  607. xMAP MultiFLEX Zika RNA Assay (Luminex Corporation)
  608. Belkin FlexVent Gas Operated Emergency Ventilator (Resuscitator)
  609. Baxter Healthcare Corporation Extracorporeal Blood Purification (EBP) Device
  610. Negative Pressure SteriDome (NPS)
  611. OSOM Flu SARS-CoV-2 Combo Home Test
  612. BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B
  613. CovAb SARS-CoV-2 Ab Test
  614. New York SARS-CoV Microsphere Immunoassay for Antibody Detection
  615. SAVe II Series Ventilator
  616. Procedure Mask with Earloops (PM345 C)
  617. Clarity COVIBLOCK COVID-19 IgG/IgM Rapid Test Cassette
  618. Alpha Genomix TaqPath SARS-CoV-2 Combo Assay
  619. ZEUS ELISA SARS-CoV-2 IgG Test System
  620. Advin COVID-19 Antigen Test @Home
  621. QuickFinder COVID-19/Flu Antigen Self Test
  622. Subsalve Oxygen Treatment Hood
  623. C-Sync COVID-19 Antigen Test
  624. T-Detect COVID Test
  625. Telepoint SARS-CoV-2 IgG/IgM Rapid Qualitative Test
  626. Vent Multiplexor
  627. RealStar Zika Virus RT-PCR Kit U.S. (altona Diagnostics GmbH)
  628. Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2
  629. Innovita 2019-nCoV Ab Test (Colloidal Gold)
  630. Test Yourself DC At-Home COVID-19 Collection Kit
  631. KimForest SARS-CoV-2 Detection Kit v1
  632. ThermoGenesis SARS-CoV-2 IgM/IgG Antibody Test Kit
  633. AirCurve 10 ST-A
  634. Pro-AmpRT SARS-CoV-2 Test
  635. Antiviral Disposition: Oseltamivir (Tamiflu), Zanamivir (Relenza), and Peramivir
  636. INDICAID COVID-19 IgM/IgG Rapid Test
  637. Zika Virus Detection by RT-PCR Test (ARUP Laboratories)
  638. QuickFinder COVID-19/Flu Antigen Self Test
  639. Bamlanivimab
  640. Moderna COVID-19 Vaccine
  641. AVA
  642. MTV1000 ventilator
  643. LightMix Ebola Zaire rRT-PCR Test
  644. cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test
  645. Ellume COVID-19 Home Test
  646. CorDx COVID-19 Ag Test
  647. FastPlex Triplex SARS-CoV-2 detection kit (RT-Digital PCR)
  648. VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack
  649. covidSHIELD
  650. LumiraDx SARS-CoV-2 Ag Test
  651. Simplexa COVID-19 Direct assay
  652. ePlex SARS-CoV-2 Test
  653. Gravity Diagnostics COVID-19 Test Home Collection Kit
  654. UMV-001 EUA
  655. Access SARS-CoV-2 IgG
  656. Aptima SARS-CoV-2 assay
  657. Flowflex Plus COVID-19 and Flu A/B Home Test
  658. FREND COVID-19 total Ab
  659. Models 6000S, T5, T7
  660. Atellica IM SARS-CoV-2 IgG (sCOVG)
  661. Discover Labs COVID-19 Assay
  662. ViraDx SARS-CoV-2/Flu A+B Rapid Antigen Tes
  663. Wilcox PATRIOT SAVR (Amended July 21, 2020)
  664. Surgical Mask, Model Number - SL3P1710
  665. Alinity m Resp-4-Plex
  666. Nano-Check COVID-19 Antigen Test
  667. Assurance SARS-CoV-2 Panel DTC
  668. AZOVA P23 At-Home COVID-19 Test Collection Kit
  669. WELLlife COVID-19 / Influenza A&B Test
  670. OSOM COVID-19 Antigen Rapid Test
  671. RightSign COVID-19 IgG/IgM Rapid Test Cassette
  672. COVI-Go SARS-CoV-2 Ag Self-Test
  673. MetaNeb 4
  674. DPP Ebola Antigen System (Chembio Diagnostic Systems, Inc.)
  675. OSUWMC COVID-19 RT-PCR test
  676. Quest PF COVID-19 PCR DTC
  677. Authorization
  678. Genus SARS-CoV-2 Assay
  679. CDC Ebola Virus VP40 Real-time RT-PCR Assay
  680. Evusheld (tixagevimab co-packaged with cilgavimab)
  681. SelfCheck cobas SARS-CoV-2 Assay
  682. ORAcollect∙RNA OR-100 and ORAcollect∙RNA ORE-100 saliva collection devices
  683. cPass SARS-CoV-2 Neutralization Antibody Detection Kit
  684. Fresenius Kabi Propoven 2%
  685. In vitro
  686. DSL COVID-19 Assay
  687. cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat System
  688. Pfizer-BioNTech COVID-19 Vaccine
  689. Infinity BiologiX TaqPath SARS-CoV-2 Assay
  690. CLEW Medical Ltd.
  691. Fitbit Flow (Amended October 8, 2020)
  692. PREVENT
  693. Tidal Medical Technologies LLC, InSee
  694. Authorization
  695. LumiraDx SARS-CoV-2 Ab Test
  696. Bebtelovimab
  697. Pneumatic Resuscitator device
  698. SARS-CoV-2 PCR Test
  699. SARS-CoV-2 real time RT-PCR test (Authorized by HHS/OASH)
  700. Helix SARS-CoV-2 Test
  701. AIRA V1.0
  702. OSOM Flu SARS-CoV-2 Combo Home Test
  703. Flexo Bi-Level ST
  704. PCL SARS-CoV-2 Real-Time RT-PCR Assay
  705. Real-Q 2019-nCoV Detection Kit
  706. Sovereign America Surgical Mask
  707. EURORealTime SARS-Cov-2
  708. EZ-SARS-CoV-2 Real-Time RT-PCR
  709. LIAISON SARS-CoV-2 S1/S2 IgG
  710. electroCore, Inc., gammaCore Sapphire CV
  711. KPMAS COVID-19 Test
  712. MiraDx SARS-CoV-2 RT-PCR assay
  713. Wantai SARS-CoV-2 RT-PCR Kit
  714. Color COVID-19 Self-Swab Collection Kit DTC
  715. Express Gene 2019-nCoV RT-PCR Diagnostic Panel
  716. Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit
  717. LumiraDx SARS-CoV-2 & Flu A/B RNA STAR Complete Assay
  718. nHale BiPAP device
  719. COVID-19 convalescent Plasma
  720. Terumo Cardiovascular CAPIOX Emergency Bypass System
  721. Metrix COVID-19 Test
  722. Medical Surgical Mask HP2723 (Large)
  723. WREN Laboratories COVID-19 Saliva Test Collection Kit DTC
  724. cd2a83b1-149c-ac67-0450-c05e7d77d6b0
  725. Xpert Xpress SARS-CoV-2 test
  726. ZXH-550
  727. OHC COVID-19/Flu Antigen Test Pro
  728. COVIage
  729. Premium PPE Amerishield Disposable Surgical Mask Model #: PPE-M-AS-SUR-lvl2-S
  730. Omnia SARS-CoV-2 Antigen Test
  731. Inform Diagnostics SARS-CoV-2 RT-PCR Assay
  732. The AscencioDx COVID-19 Test and The AscencioDx Molecular Detector
  733. STANDARD Q COVID-19 Ag Test 2.0
  734. COVID-19 RT-PCR Test
  735. Nexus High Throughput SARS-CoV-2 Assay
  736. d10fd1e2-05cf-1d56-49cb-b1692a34263c
  737. Delta Medco Disposable Surgical Face Mask with Earloops (Model DSM0001)
  738. Smart Detect SARS-CoV-2 rRT-PCR Kit
  739. Nano-Check COVID-19 Antigen At-Home Test
  740. ADVIA Centaur SARS-CoV-2 Antigen (CoV2Ag)
  741. Individual Biocontainment Unit (IBU)
  742. ReEBOV Antigen Rapid Test
  743. GoToKnow COVID-19 Antigen Rapid Test
  744. cobas SARS-CoV-2 Duo for use on the cobas 6800/8800 Systems
  745. Surgical Mask, Model Number - SM3101
  746. Gravity Diagnostics SARS-CoV-2 RT-PCR for use with DTC kits
  747. Poplar SARS-CoV-2 TMA Pooling assay
  748. Rapid Response Liberty COVID-19 IgG/IgM
  749. Luna G3 BPAP 25A- LG3700
  750. TBG SARS-CoV-2 IgG / IgM Rapid Test Kit
  751. QuickFinder COVID-19/Flu Antigen Self Test
  752. Diazyme SARS-CoV-2 Neutralizing Antibody CLIA Kit
  753. INDICAID COVID-19 Rapid Antigen At-Home Test
  754. Gowns and Other Apparel
  755. Sienna-Clarity COVIBLOCK COVID-19 IgG/IgM Rapid Test Cassette
  756. iAMP COVID-19 Detection Kit
  757. Healgen COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab)
  758. Visby Medical Respiratory Health Test
  759. ASSURE-100 Rapid COVID-19 Home Test
  760. SNL-NM 2019 nCoV Real-Time RT-PCR Diagnostic Assay
  761. iHealth COVID-19 Antigen Rapid Test
  762. GS"¢ COVID-19 RT-PCR KIT
  763. AdviseDx SARS-CoV-2 IgG II
  764. Biomeme SARS-CoV-2 Real-Time RT-PCR Test
  765. WREN Laboratories COVID-19 PCR Test DTC
  766. CovidNow SARS-CoV-2 Assay
  767. VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Reagent Pack used in combination…
  768. MaximBio ClearDetect COVID-19 Antigen Home Test
  769. iHealth COVID-19/Flu A&B Rapid Test
  770. UTHSC/UCH SARS-CoV-2-RT-PCR Assay
  771. Patient Isolation Transport Unit (PITU) Device
  772. AirCurve S T (Amended
  773. ePlex Respiratory Pathogen Panel 2
  774. TRIPLEX CII-SARS-CoV-2 rRT-PCR TEST
  775. VG70 ventilator
  776. Face Mask (non-Surgical)
  777. LIAISON XL Zika Capture IgM Assay II (DiaSorin Incorporated)
  778. Healgen COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab)
  779. Ethos Laboratories SARS-CoV-2 MALDI-TOF Assay
  780. SARS-CoV-2 IgG assay
  781. RealStar Ebolavirus RT-PCR Kit 1.0
  782. AirCurve S T
  783. Xpert Xpress SARS-CoV-2 DoD
  784. OHC COVID-19/Flu Antigen Test Pro
  785. iBreeze 30STA device
  786. COVID-19 Coronavirus Real Time PCR Kit
  787. SCONE
  788. Propofol-Lipuro 1%
  789. Ambry COVID-19 RT-PCR Test
  790. NxTAG Respiratory Pathogen Panel + SARS-CoV-2
  791. Fresenius Medical, multiFiltrate PRO System and multiBic/multiPlus Solutions
  792. Remdesivir for Certain COVID-19 Patients
  793. SCoV-2 Detect Neutralizing Ab ELISA
  794. iHealth COVID-19/Flu A&B Rapid Test Pro
  795. PowerChek 2019-nCoV Real-time PCR Kit
  796. Novavax COVID-19 Vaccine, Adjuvanted
  797. Atlan A350 and Atlan A350 XL
  798. NeoPlex COVID-19 Detection Kit
  799. QuantiVirus SARS-CoV-2 Multiplex Test Kit
  800. RealStar MERS-CoV RT-PCR Kit U.S.
  801. ADVIA Centaur SARS-CoV-2 Total (COV2T)
  802. GenePro SARS-CoV-2 Test
  803. Surgical Mask - Disposable Single-Use 4-Ply Earloop
  804. Orawell IgM/IgG Rapid Test
  805. SCoV-2 Ag Detect Rapid Test
  806. Gx HTKB SARS-CoV-2 Test
  807. NxTAG Respiratory Pathogen Panel + SARS-CoV-2
  808. WELLlife COVID-19 / Influenza A&B Home Test
  809. Kwokman Diagnostics COVID-19 Home Collection Kit
  810. CorVent RESPOND 19 Ventilator
  811. QIAreach Anti-SARS-CoV-2 Total Test
  812. V2O SAGICO SYSTEM
  813. Authorization
  814. Flowflex COVID-19 Antigen Home Test
  815. Anti-SARS-CoV-2 ELISA (IgG)
  816. InteliSwab COVID-19 Rapid Test Rx
  817. Hotgen COVID-19 Antigen Home Test
  818. Lumensource Surgical Mask Model # PKM-S201B
  819. Quest Diagnostics PF SARS-CoV-2 Assay
  820. ImmuView COVID-19 Antigen Home Test
  821. CMC Surgical Mask 10 (Model - CMC 10; ASTM Level 1)
  822. X-VENT Emergency Ventilator
  823. LabGun COVID-19 RT-PCR Kit
  824. eb168f1c-4b8a-617b-86c5-096edb64f11c
  825. SelfCheck cobas SARS-CoV-2 + Flu Assay
  826. FRL SARS CoV-2 Test
  827. Linghe Disposable, Single-Use Surgical Mask (Model Number: Best02)
  828. HVT2.0
  829. Disposable Heater Wire Breathing Circuit
  830. Ascom(US), Inc., teleCARE
  831. Authorization
  832. HealthQuest Esoterics TaqPath SARS-CoV-2 Assay
  833. Authorization
  834. SARS-CoV-2 IgG assay
  835. GenBody COVID-19 Ag Home Test
  836. cobas SARS-CoV-2 & Influenza A/B v2
  837. Sterile Water for Humidifier
  838. Rheonix COVID-19 MDx Assay
  839. E30 ventilator
  840. Lucira by Pfizer COVID-19 & Flu Home Test
  841. Atellica IM SARS-CoV-2 Total (COV2T)
  842. Pilot COVID-19 At-Home Test
  843. Ventilation Expansion Splitter (VESper)
  844. Flowflex Plus COVID-19 and Flu A/B Home Test
  845. Terumo BCT Inc. and Marker Therapeutics AG Extracorporeal Blood Purification (EBP) Devices
  846. CVS Health At Home COVID-19 Test Kit
  847. NxTAG CoV Extended Panel Assay
  848. Protektair-3 Surgical Mask Model #: PSM-3000
  849. VM series- DPAP20 Plus, DPAP25 Plus, DPAP25 Pro, DPAP30 Pro
  850. nHale BiPAP device (Amended October 3, 2022)
  851. GWU SARS-CoV-2 RT-PCR Test
  852. Cue COVID-19 Test
  853. COVID-19 RT-PCR Peptide Nucleic Acid (PNA) kit
  854. Quest Diagnostics Collection Kit for COVID-19
  855. ZEUS ELISA SARS-CoV-2 Total Antibody Test System
  856. ViroKey SARS-CoV-2 RT-PCR Test v2.0
  857. f4ab2d6f-96f3-2b17-8f6a-fbfc879244f5
  858. CareStart
  859. Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay
  860. Biocollections Worldwide SARS-Co-V-2 Assay
  861. CorDx TyFast Flu A/B & COVID-19 At Home Multiplex Rapid Test
  862. ARX Surgical Mask (Model number ARX1001)
  863. Single-Use Emergency Ventilator 2-Way Manifold
  864. BEYOND B30P BiPAP
  865. Panther 5 Model P5DLVENT
  866. Z2 Bilevel
  867. ICTC SARS-CoV-2 RT-PCR Assay
  868. New Coronavirus Nucleic Acid Detection Kit
  869. AdviseDx SARS-CoV-2 IgG II
  870. Rize Laboratory SARS nCoV-2019 Multiplexed Assay
  871. Color COVID-19 Self-Swab Collection Kit with Saline
  872. VITAL Compressor
  873. Surgical Mask (Tie-On)
  874. Sentosa SA ZIKV RT-PCR Test (Vela Diagnostics USA, Inc.)
  875. BA825W, BA825, ST830W and ST830
  876. Lucira by Pfizer COVID-19 & Flu Test
  877. Atellica IM SARS-CoV-2 Antigen (CoV2Ag)
  878. SGTi-flex COVID-19 IgG
  879. 3EO Health COVID-19 Test
  880. MED-2002-EL (50 pieces/box)
  881. Graham Medical® Surgical Masks - Model Numbers: 88037 & 88038
  882. STANDARD Q COVID-19 Ag Test 2.0
  883. UCSD RC SARS-CoV-2 Assay
  884. A/H7N9 Influenza Rapid Test
  885. Authorization
  886. Viracor SARS-CoV-2 assay DTC
  887. MASK MEDICA GV 2 GV2-GVII-202007
  888. Dimension EXL SARS-CoV-2 Total antibody assay (CV2T)
  889. Actemra (Tocilizumab)
  890. AdvanSure SARS-CoV-2 IgG(RBD) ELISA
  891. CorDx TyFast Flu A/B & COVID-19 At Home Multiplex Rapid Test

About this dataset

Emergency Use Authorizations allow the FDA to permit unapproved medical products, or unapproved uses of approved products, during a declared public health emergency.

Source: U.S. Food and Drug Administration (FDA), Emergency Use Authorizations