21 CFR 866.5775 — System, Test, Rheumatoid Factor
Immunology (IM) · Part 866 Subpart F—Immunological Test Systems · § 866.5775
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).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DHR | System, Test, Rheumatoid Factor | 2 | 144 | 3rd Party |
| NHX | Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) | 2 | 21 | 3rd Party |
| NPH | Antigen, Cartilage Oligomeric Matrix Protein (Comp) | 2 | 0 | 3rd Party |
| OQZ | Anti-Mutated Citrullinated Vimentin Igg | 2 | 1 | 3rd Party |
