Manufacturer

Ortho-Clinical Diagnostics Raritan

United StatesLegal entities : Ortho-Clinical Diagnostics, Inc. Raritan

Markets : France

Approvals : EU – class A

EU representative : Ortho-Clinical Diagnostics France (France)

Website PRRC@quidelortho.com

13 categories, 21 models including 21 on the market, 1 country

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Rhesus phenotypes	W0103030202	VITROS Anti-C (Anti- RH2) (Monoclonal) BioClone98/79 VITROS Anti-c (Anti-RH4) (Monoclonal) BioClone98/79 VITROS Anti-E (Anti-RH3) (Monoclonal) BioClone98/79 VITROS Anti-e (RH5) Monoclonal IgM Blend (human) BioClone for Slide, Tube and Microplate Tests98/79	– 98/79	EUDAMED record Report an error
Immunohaematology (blood grouping) tests - other	W01030399	VITROS Anti-Jka (Anti-JK1)(Monoclonal) BioClone98/79 VITROS Anti-Jkb (Anti-JK2)(Monoclonal) BioClone98/79 VITROS Anti-Kell (Kel1) Monoclonal IgM (human) BioClone98/79	– 98/79	EUDAMED record Report an error
Automated blood grouping analysers	W0202030102	ORTHO VISION Analyzer - BioVue VITROS2 refs ORTHO VISION Max Analyzer – Certified VITROS2 refs	A IVDR	EUDAMED record Report an error
Blood grouping analysers - consumables	W0202030185	ORTHO VISION Dilution Tray VITROS ORTHO Vision Evaporation Caps 10ml VITROS2 refs	A IVDR	EUDAMED record Report an error
HCV antibody (total)	W0105020303	VITROS ORTHO HCV 3.0 ELISA Test System with Enhanced SAVe2 refs98/79 VITROS ORTHO HCV 3.0 ELISA Test System with Enhanced SAVe (Sample Addition Verification)98/79	– 98/79	EUDAMED record Report an error
Abo grouping cells	W0103030101	VITROS ORTHO A2 Cells98/79	– 98/79	EUDAMED record Report an error
Abo sera	W0103030102	VITROS Anti-A1 Lectin (Anti-ABO4)98/79	– 98/79	EUDAMED record Report an error
Antibody 2 cell screening	W0103030302	VITROS SELECTOGEN2 refs98/79	– 98/79	EUDAMED record Report an error
Antibody 3 cell screening	W0103030308	VITROS SURGISCREEN2 refs98/79	– 98/79	EUDAMED record Report an error
Antibody identification cell panels	W0103030303	VITROS RESOLVE Panel B98/79	– 98/79	EUDAMED record Report an error
Blood grouping instruments - other	W02020399	ORTHO Workstation BioVue VITROS	A IVDR	EUDAMED record Report an error
Immunohaematology controls - other	W0103030499	VITROS Rhesus Reagent Control BioClone®98/79	– 98/79	EUDAMED record Report an error
Rhesus d	W0103030201	VITROS Anti-D (RH1) IgM + IgG BioClone98/79	– 98/79	EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

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