21 CFR 866.5270 — System, Test, C-Reactive Protein, Rhodamine
Immunology (IM) · Part 866 Subpart F—Immunological Test Systems · § 866.5270
Identification
A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DCH | System, Test, C-Reactive Protein, Rhodamine | 2 | 1 | 3rd Party |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 2 | 126 | 3rd Party |
| DCN | System, Test, C-Reactive Protein | 2 | 70 | 3rd Party |
| NQD | Cardiac C-Reactive Protein, Antigen, Antiserum, And Control | 2 | 19 | 3rd Party |
