Manufacturer

Ortho-Clinical Diagnostics Rochester

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

Markets : France

Approvals : EU – class A

EU representative : Ortho-Clinical Diagnostics France (France)

Website PRRC@quidelortho.com

12 categories, 31 models including 30 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
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Category	EMDN code	Registered models	Class	Contact
Chemistry analysers - consumables	W0201010185	VITROS Chemistry Products BSA VITROS Chemistry Products Electrolyte Reference Fluid (ERF) 800 VITROS Chemistry Products Electrolyte Reference Fluid 300 - 6mL Punched / 30 per box VITROS Chemistry Products FS Diluent Pack 1 box/3 packs (Apo Diluent/UED) VITROS Chemistry Products FS Diluent Pack 2 box/3 packs (BSA/Saline) 6 others VITROS Chemistry Products FS Diluent Pack 3 box/3 packs (Specialty Diluent/Water) VITROS Chemistry Products FS Diluent Pack 4 (DAT Diluent/DAT Diluent 2) VITROS Chemistry Products FS Reconstitution Diluent VITROS Chemistry Products MicroSensor Check Fluids I and II VITROS Chemistry Products Specialty Diluent VITROS Chemistry Products Urine Electrolyte Diluent ((Na+) and (K+))	A IVDR	EUDAMED record Report an error
Pipettes, tips without filter	W0503020202	VITROS FS MicroTips VITROS MicroTips VITROS Products FS MicroTip Bulk VITROS VersaTips VITROS XT3400 VersaTip Tray	A IVDR	EUDAMED record Report an error
Mixed panel multiparameter analysers - moderate routine (throughput > 800 and <= 2000 test/h)	W0201030102	VITROS 5600 Integrated System2 refs VITROS XT 3400 VITROS XT 76002 refs	A IVDR	EUDAMED record Report an error
Automated immunochemistry analysers - low routine (throughput <= 100 test/h)	W0201020101	VITROS 3600 Immunodiagnostic System2 refs VITROS ECI IMMUNODIAGNOSTIC SYSTEM2 refs	A IVDR	EUDAMED record Report an error
Samples analyses, plastic cuvettes	W0503010203	FS Cuvettes VITROS VITROS Microsample Cups	A IVDR	EUDAMED record Report an error
Enhancement media (e.g. bovine albumin, liss, peg)	W0103030306	ORTHO BLISS (4 x 50 ml bottles) VITROS2 refs ORTHO Antibody Enhancement Solution VITROS (no longer marketed)	A IVDR	EUDAMED record Report an error
Antibody detection (immunohaematology) - other	W0103030399	0.8% ORTHO Red Cell Diluent (1 X 50 ml) VITROS2 refs	A IVDR	EUDAMED record Report an error
Chemistry analysers - moderate to high routine (random access without ise mode test/h > 800 and <= 1.200)	W0201010103	VITROS 4600 Chemistry System2 refs	A IVDR	EUDAMED record Report an error
Homocysteine	W0103020614	VITROS Chemistry Products HCY 2 Reagent98/79	– 98/79	EUDAMED record Report an error
Limited panel blood grouping analysers - consumables	W0202030285	Ortho BioVue System Liner VITROS	A IVDR	EUDAMED record Report an error
Samples analyses, plastic containers - other	W050301029099	VITROS Chemistry Products UD01 Packs (EMPTY) BOX/6PACKS3 refs	A IVDR	EUDAMED record Report an error
Samples analyses, plastic microtubes - accessories	W050301020280	VITROS Pierceable Caps	A IVDR	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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