FDA device listing
Aptima HIV-1 Qualitative Assay
FDA device listing 1262841644 · Grifols Diagnostic Solutions Inc.
Key facts
| Proprietary names | Aptima HIV-1 Qualitative Assay |
|---|---|
| Owner/operator | Grifols Diagnostic Solutions Inc. |
| Owner/operator number | 10051675 |
| Product codes | MZF |
| Device names | MZF - Test, Hiv Detection |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.3956 |
| Review panels | Microbiology |
| Registered establishments | Grifols Diagnostic Solutions Inc. |
| Establishment registrations | 2032600 |
| FEI numbers | 3003460312 |
| Establishment operations | Contract Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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