19 results · 14ms · Sources: EU EUDAMED, US FDA

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ROCHE DIAGNOSTICS CK-MB

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID ASSAY; ROCHE DIAGNOSTICS CARDIAC D-DIMER CONTROLS

FDA 510(k)
FDA Class 2 ·Hematology

ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS CALIBRATOR CALIBRATOR FOR AUTOMATED SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ROCHE DIAGNOSTICS OMNI S ANALYZER

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ROCHE DIAGNOSTICS HITACHI BICARBONATE LIQUID

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO

FDA 510(k)
FDA Class 2 ·Immunology

ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ROCHE DIAGNOSTICS ELECSYS AFP CALSET II

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER

FDA 510(k)
FDA Class 2 ·Hematology

ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON COBAS INTEGRA; ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON HITACHI

FDA 510(k)
FDA Class 2 ·Hematology

ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2

FDA 510(k)
FDA Class 2 ·Immunology

ROCHE DIAGNOSTICS INFLUENZA A/B RAPID TEST

FDA 510(k)
FDA Class 2 ·Microbiology

ROCHE DIAGNOSTICS COBAS ELECSYS PROLACTIN II CALSET

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2

FDA 510(k)
FDA Class 2 ·Immunology

ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2

FDA 510(k)
FDA Class 2 ·Immunology

ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM LIQUID TOTAL BILIRUBIN REAGENT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION LIQUID DIRECT BILIRUBIN REAGENT, CATALOG NUMBER 1877844

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KIT

FDA 510(k)
FDA Class 2 ·Immunology