C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET
Device Facts
| Record ID | K002651 |
|---|---|
| Device Name | C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET |
| Applicant | Pointe Scientific, Inc., |
| Product Code | DCK · Immunology |
| Decision Date | Oct 13, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5270 |
| Device Class | Class 2 |
Regulatory Classification
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.
