DCH · System, Test, C-Reactive Protein, Rhodamine
Immunology · 21 CFR 866.5270 · Class 2
Overview
| Product Code | DCH |
|---|---|
| Device Name | System, Test, C-Reactive Protein, Rhodamine |
| Regulation | 21 CFR 866.5270 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
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).
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K964687 | N LATEX CRP MONO REAGENT | Behring Diagnostics, Inc. | Dec 16, 1996 | SESE |
Top Applicants
- Behring Diagnostics, Inc. — 1 clearance
