VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATORS MANUFACTURED BY ORTHO-CLINICAL DIAGNOSTICS

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Request for Information Form	Contact Information
Company Name	ORTHO-CLINICAL DIAGNOSTICS
Address	FOREST FARM ESTATE WHITCHURCH
City, State, Zip	CARDIFF,
Country	UK
FDA Owner/Operator Phone	585-453-4469
FDA Medical Specialty Code	MI - Microbiology
FDA Product Code	MZO
FDA Classification Name	ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS
FDA Device Classification Code	Premarket Approval
FDA Regulation Number	NULL
FDA Common Generic Name	ANTI HCV ASSAY
FDA Proprietary Device Name	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATORS
FDA Owner / Operator Number	9011934
FDA Owner / Operator Name	ORTHO-CLINICAL DIAGNOSTICS, INC.
FDA Establishment Registration Number	9680658
FDA Registered Establishment Name	ORTHO-CLINICAL DIAGNOSTICS
FDA Operation Code(s)	MM - Manufacturer MS - Specification Developer
FDA Listing Date	12-01-05
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

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8	ST. PAUL BIOTECH 11555 MONARCH ST. GARDEN GROVE, CA 92841 US 714-903-1000 / 714-903-1000 226	MULTIPLE	HEPATITIS C VIRUS TEST
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