NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE DILUENT)
Device Facts
| Record ID | K011128 |
|---|---|
| Device Name | NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE DILUENT) |
| Applicant | Nichols Institute Diagnostics |
| Product Code | CIB · Clinical Chemistry |
| Decision Date | Sep 6, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1085 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An angiotensin I and renin test system is a device intended to measure the level of angiotensin I generated by renin in plasma. Angiotensin I measurements are used in the diagnosis and treatment of certain types of hypertension.
