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Electrophoretic Separation, Alkaline Phosphatase Isoenzymes

FDA product code CIN · Class 2 · Clinical Chemistry

12
Registered devices
4
Adverse events
7
Recalls
26
510(k) clearances

Devices with this code

UniQ® PINP RIA — Aidian OyOstase®+ BAP EIA — IMMUNODIAGNOSTIC SYSTEMS LIMITEDMicroVue — QUIDEL CORPORATIONTITAN GEL Alkaline Phosphatase Kit — HELENA LABORATORIES CORPORATIONTITAN GEL Alkaline Phosphatase Reagent Kit — HELENA LABORATORIES CORPORATIONAccess Ostase — Beckman Coulter, Inc.SPIFE Alkaline Phosphatase Reagent Kit — HELENA LABORATORIES CORPORATIONSPIFE ALP Separation Enhancer — HELENA LABORATORIES CORPORATIONSPIFE Alkaline Phosphatase Gel Kit — HELENA LABORATORIES CORPORATIONAlkaline Phosphatase Indolyl Blue Reagent Kit — HELENA LABORATORIES CORPORATIONSPIFE Alkaline Phosphatase-20,40 Gel Kit — HELENA LABORATORIES CORPORATIONIDS-iSYS Ostase® BAP — IMMUNODIAGNOSTIC SYSTEMS LIMITED

Recent recalls

DateFirmReason
2016-07-14Diagnostic Hybrids, Inc.There is a possibility of low volume and/or leaking standard bottles.
2012-08-10Immunodiagnostics Systems LtdIt has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with IVD labels although they are not registered for sal
2012-08-10Immunodiagnostics Systems LtdIt has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with IVD labels although they are not registered for sal
2012-08-10Immunodiagnostics Systems LtdIt has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with IVD labels although they are not registered for sal
2011-11-10Beckman Coulter Inc.The recall was initiated because Beckman confirmed that the Access Ostase Calibrator and QC lots do not meet expiration date claims. The Access Ostase Reagent
2011-11-10Beckman Coulter Inc.The recall was initiated because Beckman confirmed that the Access Ostase Calibrator and QC lots do not meet expiration date claims. The Access Ostase Reagent
2011-06-22Beckman Coulter Inc.The Access Ostase reagent lot 021281 shows instability resulting in falsely high patient results.

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