1,603 results · 176ms · Sources: EU EUDAMED, US FDA

Ortho-Clinical Diagnostics, Inc. Raritan

Manufacturer
🇺🇸 United States·1 Importer

Ortho-Clinical Diagnostics, Inc. Rochester

Manufacturer
🇺🇸 United States·1 Importer

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

FDA Pre-Market Approval
FDA Class 3 ·HBSAG REAGENT PACK/CALIBRATOR & CONFIRMATORY KIT

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·ANTI-HCV REAGENT PACK AND CALIBRATOR

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

FDA Pre-Market Approval
FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK AND CALIBRATOR

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

FDA Pre-Market Approval
FDA Class 3 ·ANTI-HBC REAGENT PACK AND CALIBRATOR

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

FDA Pre-Market Approval
FDA Class 3 ·ANTI-HBC REAGENT PACK AND CALIBRATOR

VITROS HPT Reagent

FDA registration
ORTHO-CLINICAL DIAGNOSTICS, INC.·1 product·🇺🇸 United States

VITROS PCP Reagent

FDA registration
ORTHO-CLINICAL DIAGNOSTICS, INC.·3 products·🇺🇸 United States

VITROS Fe Slides

FDA registration
ORTHO-CLINICAL DIAGNOSTICS, INC.·1 product·🇺🇸 United States

VITROS 4600 Chemistry System

FDA registration
ORTHO-CLINICAL DIAGNOSTICS, INC.·3 products·🇺🇸 United States

VITROS Calibrator Kit 24

FDA registration
ORTHO-CLINICAL DIAGNOSTICS, INC.·3 products·🇺🇸 United States

VITROS UPRO Performance Verifiers

FDA registration
ORTHO-CLINICAL DIAGNOSTICS, INC.·3 products·🇺🇸 United States

VITROS Mg Slides

FDA registration
ORTHO-CLINICAL DIAGNOSTICS, INC.·2 products·🇺🇸 United States

VITROS CRP Performance Verifiers

FDA registration
ORTHO-CLINICAL DIAGNOSTICS, INC.·1 product·🇺🇸 United States

VITROS Anti-HBc IgM Controls

FDA registration
ORTHO-CLINICAL DIAGNOSTICS, INC.·1 product·🇺🇸 United States

VITROS Estradiol Calibrator

FDA registration
ORTHO-CLINICAL DIAGNOSTICS, INC.·2 products·🇺🇸 United States

D3 Fastpoint L-DFA Influenza A/INFL

FDA registration
Ortho-Clinical Diagnostics, Inc.·1 product·🇺🇸 United States

Sofia hCG FIA

FDA registration
Ortho-Clinical Diagnostics, Inc.·1 product·🇺🇸 United States

QuickVue+ Strep A

FDA registration
Ortho-Clinical Diagnostics, Inc.·1 product·🇺🇸 United States