Radioimmunoassay, Angiotensin I And Renin
The Radioimmunoassay, Angiotensin I and Renin test system (product code CIB) is an in-vitro diagnostic device used in clinical chemistry to measure angiotensin I and plasma renin activity using a radioimmunoassay method, supporting the evaluation of the renin-angiotensin-aldosterone system and the diagnosis of hypertension and adrenal disorders. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 862.1085 in the Clinical Chemistry medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.
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Basic Information
- Product Code
- CIB
- Device Class
- FDA class 2
- Regulation Number
- 862.1085
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 16 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K123763 | IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS | Dec 24, 2013 | Substantially Equivalent | Immunodiagnostic Systems , Ltd. |
| K121944 | LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT | Jan 01, 2013 | Substantially Equivalent | DiaSorin, Inc. |
| K062120 | CISBIO RENIN RIA TEST | Mar 30, 2007 | Substantially Equivalent | Cis Bio International |
| K061758 | ACTIVE RENIN IRMA | Jul 28, 2006 | Substantially Equivalent | Diagnostic Systems Laboratories, Inc. |
| K011128 | NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE DILUENT) | Sep 06, 2001 | Substantially Equivalent | Nichols Institute Diagnostics |
| K981607 | ACTIVE RENIN IRMA MODEL NUMBER DSL-25100 | May 27, 1998 | Substantially Equivalent | Diagnostic Systems Laboratories, Inc. |
| K954299 | BUHLMANN ANGIOSTENSIN II RIA | Oct 19, 1995 | Substantially Equivalent | Buhlmann Laboratories AG |
| K940004 | AI-PHOTODIAGNOSTIC | Aug 04, 1995 | Substantially Equivalent | Pharmarceutical Discovery Corp. |
| K925998 | ACTIVE RENIN IMMUNORADIOMETRIC ASSAY | Jan 06, 1993 | Substantially Equivalent | Nichols Institute Diagnostics |
| K850054 | RIANEN ANGIOTENSIN I RADIOIMMUNOASSAY KI | Mar 29, 1985 | Substantially Equivalent | E.I. Dupont DE Nemours & Co., Inc. |
| K842966 | RENIN RADIOIMMUNOASSAY TEST KIT | Oct 11, 1984 | Substantially Equivalent | Serono Diagnostics, Inc. |
| K833777 | ANGIOTENSIN CONVERTING ENZYME | Jan 30, 1984 | Substantially Equivalent | Immuno-Diagnostic Laboratories |
| K831694 | RENAK | Jul 19, 1983 | Substantially Equivalent | Hoffmann-La Roche, Inc. |
| K820616 | ANGIOTENSIS I-SQUIBB RADIOIMMUNOASSAY | Mar 26, 1982 | Substantially Equivalent | E. R. Squibb & Sons, Inc. |
| K800774 | RENCTK | Apr 21, 1980 | Substantially Equivalent | Sorin Biomedica, Fiat, USA, Inc. |
| K761267 | ANGIOTENSIN I IMMUTOPE KIT | Dec 30, 1976 | Substantially Equivalent | Squibb & Sons, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.