19 results
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11ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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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