2 results
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35ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Product Usage - CONSULT Diagnostics hCG Controls are intended to validate the performance of qualitative hCG urine procedures and immunochromatographic devices.
FDA Recall
Terminated
·Biochemical Diagnostics Inc·Product code JJX·September 14, 2015
CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Product Usage - CONSULT Diagnostics hCG Controls are intended to validate the performance of qualitative hCG urine procedures and immunochromatographic devices.
FDA Enforcement
Class III
·Terminated·Biochemical Diagnostics Inc·December 2, 2015