FDA device listing
hCG Pregnancy Mid-Stream Test,Instant-View Pregnancy Mid-Stream Test
FDA device listing 1585457860 · ALFA SCIENTIFIC DESIGNS, INC.
Key facts
| Proprietary names | hCG Pregnancy Mid-Stream Test,Instant-View Pregnancy Mid-Stream Test |
|---|---|
| Owner/operator | ALFA SCIENTIFIC DESIGNS, INC. |
| Owner/operator number | 9034872 |
| Premarket submissions | K984080 |
| 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 | ALFA SCIENTIFIC DESIGNS, INC. |
| Establishment registrations | 2060833 |
| FEI numbers | 3001452245 |
| Establishment operations | Contract Manufacturer, Manufacturer, Repackager/Relabeler |
| 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