2,078 results · 113ms · Sources: EU EUDAMED, US FDA

cobas INTEGRA CYCLOSPORINE SAMP PRETREAT

FDA registration
ROCHE DIAGNOSTICS GMBH·1 product·🇩🇪 Germany

COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST

FDA registration
ROCHE DIAGNOSTICS GMBH·1 product·🇩🇪 Germany

ASLO TZ, 150Tests, cobas c

FDA registration
ROCHE DIAGNOSTICS GMBH·1 product·🇩🇪 Germany

ELECSYS FT3

FDA registration
ROCHE DIAGNOSTICS GMBH·2 products·🇩🇪 Germany

Ionify iDIL cobas i

FDA registration
ROCHE DIAGNOSTICS GMBH·1 product·🇩🇪 Germany

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ELECSYS ANTI-HBC-IGM ON COBAS E 411

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ELECSYS ANTI-HBC-IGM ON MODULAR ANALYTICS E170

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ELECSYS ANTI-HBC-IGM ON COBAS E 601

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E601

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ELECSYS ANTI-HBC IMMUNOASSAY ON THE MODULAR ANALYSTICS E170 IMMUNOASSAY ANALYZER

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ELECSYS ANTI-HBS IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HBS

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval
FDA Class 3 ·ELECSYS TOTAL PSA IMMUNOASSAY

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON E170 IMMUNOASSAY ANALYZER

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E411

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval
FDA Class 3 ·ELECSYS FREE PSA IMMUNOASSAY

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ELECSYS HBSAG IMMUNOASSAY & CONFIRMATORY & PRECICONTROL HBSAG

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ELECSYS ANTI-HBC IMMUNOASSAY ON THE ELECSYS 2010 IMMUNOASSAY ANALYZER

MagNA Pure 24 Piercing Tool

FDA registration
Roche Diagnostics Automation Solutions GmbH·1 product·🇩🇪 Germany

CCM Vertical Overhead Conveyor Unit (1m)

FDA registration
Roche Diagnostics Automation Solutions GmbH·1 product·🇩🇪 Germany

Tinaquant IgA Gen2

FDA UDI
Roche Diagnostics GmbH·04015630919680·