Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart B — Clinical Chemistry Test Systems](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems) → [21 CFR 862.1085](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1085) → CIB — Radioimmunoassay, Angiotensin I And Renin

# CIB · Radioimmunoassay, Angiotensin I And Renin

_Clinical Chemistry · 21 CFR 862.1085 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIB

## Overview

- **Product Code:** CIB
- **Device Name:** Radioimmunoassay, Angiotensin I And Renin
- **Regulation:** [21 CFR 862.1085](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1085)
- **Device Class:** 2
- **Review Panel:** [Clinical Chemistry](/submissions/CH)
- **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.

## Recent Cleared Devices (16 of 16)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K123763](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIB/K123763.md) | 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](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIB/K121944.md) | LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT | DiaSorin, Inc. | Jan 1, 2013 | SESE |
| [K062120](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIB/K062120.md) | CISBIO RENIN RIA TEST | Cis Bio International | Mar 30, 2007 | SESE |
| [K061758](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIB/K061758.md) | ACTIVE RENIN IRMA | Diagnostic Systems Laboratories, Inc. | Jul 28, 2006 | SESE |
| [K011128](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIB/K011128.md) | NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE DILUENT) | Nichols Institute Diagnostics | Sep 6, 2001 | SESE |
| [K981607](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIB/K981607.md) | ACTIVE RENIN IRMA MODEL NUMBER DSL-25100 | Diagnostic Systems Laboratories, Inc. | May 27, 1998 | SESE |
| [K954299](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIB/K954299.md) | BUHLMANN ANGIOSTENSIN II RIA | Buhlmann Laboratories AG | Oct 19, 1995 | SESE |
| [K940004](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIB/K940004.md) | AI-PHOTODIAGNOSTIC | Pharmarceutical Discovery Corp. | Aug 4, 1995 | SESE |
| [K925998](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIB/K925998.md) | ACTIVE RENIN IMMUNORADIOMETRIC ASSAY | Nichols Institute Diagnostics | Jan 6, 1993 | SESE |
| [K850054](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIB/K850054.md) | RIANEN ANGIOTENSIN I RADIOIMMUNOASSAY KI | E.I. Dupont DE Nemours & Co., Inc. | Mar 29, 1985 | SESE |
| [K842966](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIB/K842966.md) | RENIN RADIOIMMUNOASSAY TEST KIT | Serono Diagnostics, Inc. | Oct 11, 1984 | SESE |
| [K833777](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIB/K833777.md) | ANGIOTENSIN CONVERTING ENZYME | Immuno-Diagnostic Laboratories | Jan 30, 1984 | SESE |
| [K831694](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIB/K831694.md) | RENAK | Hoffmann-La Roche, Inc. | Jul 19, 1983 | SESE |
| [K820616](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIB/K820616.md) | ANGIOTENSIS I-SQUIBB RADIOIMMUNOASSAY | E. R. Squibb & Sons, Inc. | Mar 26, 1982 | SESE |
| [K800774](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIB/K800774.md) | RENCTK | Sorin Biomedica, Fiat, USA, Inc. | Apr 21, 1980 | SESE |
| [K761267](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIB/K761267.md) | ANGIOTENSIN I IMMUTOPE KIT | Squibb & Sons, Inc. | Dec 30, 1976 | SESE |

## Top Applicants

- Diagnostic Systems Laboratories, Inc. — 2 clearances
- Nichols Institute Diagnostics — 2 clearances
- Buhlmann Laboratories AG — 1 clearance
- Cis Bio International — 1 clearance
- DiaSorin, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIB](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIB)

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