CIB · Radioimmunoassay, Angiotensin I And Renin
Clinical Chemistry · 21 CFR 862.1085 · Class 2
Overview
| Product Code | CIB |
|---|---|
| Device Name | Radioimmunoassay, Angiotensin I And Renin |
| Regulation | 21 CFR 862.1085 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
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.
Classification Rationale
Class II.
Cleared Devices (16)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K123763 | IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS | Immunodiagnostic Systems , Ltd. | Dec 24, 2013 | SESE |
| K121944 | LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT | DiaSorin, Inc. | Jan 1, 2013 | SESE |
| K062120 | CISBIO RENIN RIA TEST | Cis Bio International | Mar 30, 2007 | SESE |
| K061758 | ACTIVE RENIN IRMA | Diagnostic Systems Laboratories, Inc. | Jul 28, 2006 | SESE |
| K011128 | NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE DILUENT) | Nichols Institute Diagnostics | Sep 6, 2001 | SESE |
| K981607 | ACTIVE RENIN IRMA MODEL NUMBER DSL-25100 | Diagnostic Systems Laboratories, Inc. | May 27, 1998 | SESE |
| K954299 | BUHLMANN ANGIOSTENSIN II RIA | Buhlmann Laboratories AG | Oct 19, 1995 | SESE |
| K940004 | AI-PHOTODIAGNOSTIC | Pharmarceutical Discovery Corp. | Aug 4, 1995 | SESE |
| K925998 | ACTIVE RENIN IMMUNORADIOMETRIC ASSAY | Nichols Institute Diagnostics | Jan 6, 1993 | SESE |
| K850054 | RIANEN ANGIOTENSIN I RADIOIMMUNOASSAY KI | E.I. Dupont DE Nemours & Co., Inc. | Mar 29, 1985 | SESE |
| K842966 | RENIN RADIOIMMUNOASSAY TEST KIT | Serono Diagnostics, Inc. | Oct 11, 1984 | SESE |
| K833777 | ANGIOTENSIN CONVERTING ENZYME | Immuno-Diagnostic Laboratories | Jan 30, 1984 | SESE |
| K831694 | RENAK | Hoffmann-La Roche, Inc. | Jul 19, 1983 | SESE |
| K820616 | ANGIOTENSIS I-SQUIBB RADIOIMMUNOASSAY | E. R. Squibb & Sons, Inc. | Mar 26, 1982 | SESE |
| K800774 | RENCTK | Sorin Biomedica, Fiat, USA, Inc. | Apr 21, 1980 | SESE |
| K761267 | ANGIOTENSIN I IMMUTOPE KIT | Squibb & Sons, Inc. | Dec 30, 1976 | SESE |
Top Applicants
- Nichols Institute Diagnostics — 2 clearances
- Diagnostic Systems Laboratories, Inc. — 2 clearances
- Squibb & Sons, Inc. — 1 clearance
- Sorin Biomedica, Fiat, USA, Inc. — 1 clearance
- Serono Diagnostics, Inc. — 1 clearance
