FDA device listing
DASH® Negative Control,DASH® Rapid PCR Instrument,DASH® SARS-CoV-2 & Flu A B Positive Control,DASH® SARS-CoV-2 & Flu A/B…
FDA device listing 1456097506 · Nuclein, LLC
Key facts
| Proprietary names | DASH® Negative Control,DASH® Rapid PCR Instrument,DASH® SARS-CoV-2 & Flu A B Positive Control,DASH® SARS-CoV-2 & Flu A/B Test |
|---|---|
| Owner/operator | Nuclein, LLC |
| Owner/operator number | 10092415 |
| Premarket submissions | K241652 |
| Product codes | NSU, QOF |
| Device names | NSU - Instrumentation For Clinical Multiplex Test Systems, QOF - Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.2570, 866.3981 |
| Review panels | Clinical Chemistry, Microbiology |
| Registered establishments | Nuclein, LLC |
| Establishment registrations | 3014515702, 3035381641 |
| FEI numbers | 3014515702, 3035381641 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database