2 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Iii
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A. MENARINI diagnostics Hb 9210 PREMIER, LEVEL1, LEVEL II, Hemoglobin A1c Controls for hemoglobin A1c Assay, REF 45052, part number 05-01-0926, A1c analysis
FDA Enforcement
Class III
·Terminated·Primus Corporation dba Trinity Biotech·December 7, 2022
Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-0020, Part number 05-01-0040B, A1c analysis
FDA Enforcement
Class III
·Terminated·Primus Corporation dba Trinity Biotech·December 7, 2022