FDA device listing
RF IgM (Rheumatoid Factor) ELISA
FDA device listing 1172494774 · BIOCHECK, INC.
Key facts
| Proprietary names | RF IgM (Rheumatoid Factor) ELISA |
|---|---|
| Owner/operator | BIOCHECK, INC. |
| Owner/operator number | 9033543 |
| Premarket submissions | K961277 |
| Product codes | DHR |
| Device names | DHR - System, Test, Rheumatoid Factor |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.5775 |
| Review panels | Immunology |
| Registered establishments | DRG INSTRUMENTS GMBH, DRG International, Inc. |
| Establishment registrations | 2245285, 3002800697 |
| FEI numbers | 2245285, 3002800697 |
| Establishment operations | Complaint File Establishment, Manufacturer, Repackager/Relabeler |
| 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