FDA device listing
Alere hCG Cassette (20 mIU/mL) in Urine,Alere hCG Combo Cassette (20/10 mIU/mL) for Urine or Serum,Cardinal Health hCG…
FDA device listing 1952616054 · ABBOTT LABORATORIES
Key facts
| Proprietary names | Alere hCG Cassette (20 mIU/mL) in Urine,Alere hCG Combo Cassette (20/10 mIU/mL) for Urine or Serum,Cardinal Health hCG Combo Rapid Test,McKesson CONSULT Diagnostics hCG Combo Tests Cassette,McKesson CONSULT Diagnostics hCG Urine Tests Cassette,Medline hCG Combo+ Pregnancy Test Cassette,Sure-Vue Serum/Urine hCG-STAT |
|---|---|
| Owner/operator | ABBOTT LABORATORIES |
| Owner/operator number | 1415939 |
| Premarket submissions | K062361 |
| Product codes | JHI |
| Device names | JHI - Visual, Pregnancy Hcg, Prescription Use |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.1155 |
| Review panels | Clinical Chemistry |
| Registered establishments | ABON BIOPHARM (HANGZHOU) CO., LTD., Alere San Diego, Inc. |
| Establishment registrations | 2027969, 3005641941 |
| FEI numbers | 1000125596, 3005641941 |
| Establishment operations | Contract Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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