OQZ · Anti-Mutated Citrullinated Vimentin Igg
Immunology · 21 CFR 866.5775 · Class 2
Overview
| Product Code | OQZ |
|---|---|
| Device Name | Anti-Mutated Citrullinated Vimentin Igg |
| Regulation | 21 CFR 866.5775 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
Identification
A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K092399 | ANTI-MUTATED CITRULLINATED VIMENTIN EIA | Orgentec Diagnostika GmbH | Jul 1, 2010 | SESE |
Top Applicants
- Orgentec Diagnostika GmbH — 1 clearance
