6 results
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8ms
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Sources: EU EUDAMED, US FDA
Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator The ALP CAL is an in vitro diagnostic product for the calibration of the Alkaline Phosphatase method on the Dimension Vista" System.
FDA Enforcement
Class III
·Terminated·Siemens Healthcare Diagnostics, Inc.·April 3, 2013
Cardinal Health Beta-Hydroxybutyrate LiquiColor for Synchron CX/LX/DX. in vitro diagnostic reagent.
FDA Enforcement
Class III
·Terminated·Stanbio Laboratory, LP·August 11, 2021
Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent.
FDA Enforcement
Class III
·Terminated·Stanbio Laboratory, LP·August 11, 2021
Synchron CX/DX/LX Beta-Hydroxybutyrate . in vitro diagnostic reagent.
FDA Enforcement
Class III
·Terminated·Stanbio Laboratory, LP·August 11, 2021
Beta-Hydroxybutyrate LiquiColor. in vitro diagnostic reagent.
FDA Enforcement
Class III
·Terminated·Stanbio Laboratory, LP·August 11, 2021
Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic reagent.
FDA Enforcement
Class III
·Terminated·Stanbio Laboratory, LP·August 11, 2021