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Radioimmunoassay, Angiotensin I And Renin

FDA product code CIB · Class 2 · Clinical Chemistry

4
Registered devices
0
Adverse events
4
Recalls
16
510(k) clearances

Devices with this code

Angiotensin II RIA — Bühlmann Laboratories AGIDS-iSYS Direct Renin — IMMUNODIAGNOSTIC SYSTEMS LIMITEDACTIVE RENIN — CISBIO BIOASSAYSACTIVE RENIN — CISBIO BIOASSAYS

Recent recalls

DateFirmReason
2012-01-20Beckman Coulter Inc.The recall was initiated because Beckman Coulter has confirmed that the Active Renin IRMA Test Kit may exhibit a decrease in stability of the coated tubes. As
2009-10-12Diasorin Inc.The kit control provided with the GammaCoat Plasma Renin Activity kit was labeled with the incorrect range.
2003-07-28Perkinelmer Life Sciences, Inc.Incorrect calibration standard value may result in 25% higher assay values for controls and patient samples
2003-07-28Perkinelmer Life Sciences, Inc.Incorrect calibration standard value may result in 25% higher assay values for controls and patient samples

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.