FDA device listing
ACRO hCG Pregnancy Combo Test,Alltest Pregnancy Rapid Combo Test Cassette,Atida hCG Pregnancy Rapid Combo Test,CHOSEN…
FDA device listing 1967934180 · Hangzhou AllTest Biotech Co.,Ltd
Key facts
| Proprietary names | ACRO hCG Pregnancy Combo Test,Alltest Pregnancy Rapid Combo Test Cassette,Atida hCG Pregnancy Rapid Combo Test,CHOSEN hCG Pregnancy Combo Rapid Test Cassette Rx,Citest hCG Pregnancy Combo Rapid Test,CLARITY hCG Combo Cassette,Identify Health Pregnancy Rapid Combo Test Cassette,Medline hCG Combo Pregnancy Test Cassette |
|---|---|
| Owner/operator | Hangzhou AllTest Biotech Co.,Ltd |
| Owner/operator number | 10050156 |
| Premarket submissions | K203272 |
| 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 | Hangzhou AllTest Biotech Co.,Ltd |
| Establishment registrations | 3012073813, 3027519599, 3043127647 |
| FEI numbers | 3012073813, 3027519599, 3043127647 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 100–999 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