6 results
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6ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Iii
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VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use only.VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated System - Product Code: 8231474
FDA Enforcement
Class III
·Ongoing·Ortho Clinical Diagnostics Inc·November 25, 2020
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