COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II
Device Facts
| Record ID | K000534 |
|---|---|
| Device Name | COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II |
| Applicant | Roche Diagnostics Corp. |
| Product Code | DHR · Immunology |
| Decision Date | Apr 5, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5775 |
| Device Class | Class 2 |
Regulatory Classification
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.
