FDA device listing
IMMULITE 2000 AFP,IMMULITE 2000 AFP (AF),IMMULITE AFP Control Module
FDA device listing 1260715183 · SIEMENS HEALTHCARE DIAGNOSTICS INC.
Key facts
| Proprietary names | IMMULITE 2000 AFP,IMMULITE 2000 AFP (AF),IMMULITE AFP Control Module |
|---|---|
| Owner/operator | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Owner/operator number | 9096044 |
| Premarket submissions | P010007 |
| Product codes | LOK |
| Device names | LOK - Kit, Test, Alpha-Fetoprotein For Neural Tube Defects |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.LOK |
| Review panels | Immunology |
| Registered establishments | Siemens Healthcare Diagnostics Inc., SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED |
| Establishment registrations | 2432235, 3002806944 |
| FEI numbers | 2432235, 3002806944 |
| Establishment operations | Complaint File Establishment, Specification Developer, 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