MULTIPLE MANUFACTURED BY ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.

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Request for Information Form	Contact Information
Company Name	ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.
Address	KM 58.0, CARRETERA 2 CRUCE DAVILA
City, State, Zip	BARCELONETA, PR 00617
Country	US
FDA Owner/Operator Phone	847-937-6100
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-HEPATITIS C VIRUS
FDA Proprietary Device Name	MULTIPLE
FDA Owner / Operator Number	1415939
FDA Owner / Operator Name	ABBOTT LABORATORIES
FDA Establishment Registration Number	2623532
FDA Registered Establishment Name	ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	12-22-06
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Our records indicate that the following medical device companies may manufacture a similar device.

	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	ABBOTT LABORATORIES 100 AND 200 ABBOTT PARK RD. ABBOTT PARK, IL 60064 US 847-937-6100 / 847-938-3471	HCV 2.0 EIA	HEPATITIS C VIRUS
2	ALFA SCIENTIFIC DESIGNS, INC. 13200 GREGG ST. POWAY, CA 92064 US 858-513-3888 / 858-513-3888 314	INSTANT-VIEW SERUM TEST	HCV SERUM TEST
3	GLOBAL BUSINESS SUPPORT SYSTEMS, INC. 9520 CHESAPEAKE DRIVE, #601 SAN DIEGO, CA 92123 US 858-430-2800 / 858-430-2800 112	HEPATITIS C CHECK TEST SYSTEM	HOME HCV TEST SYSTEM
4	HOME ACCESS HEALTH CORP. 2401 W. HASSELL RD. SUITE 1510 HOFFMAN ESTATES, IL 60169 US 847-781-2526 / 847-781-2522	HEPATITIS C CHECK	HOME HCV TEST SYSTEM
5	ORTHO-CLINICAL DIAGNOSTICS FOREST FARM ESTATE WHITCHURCH CARDIFF, CF14 7YT UK 585-453-4469 / 585-453-4152	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATORS	ANTI HCV ASSAY
6	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 BENEDICT AVENUE TARRYTOWN, NY 10591 US 914-524-2955 / 914-524-2955	ADVIA CENTAUR HEPATITIS C ASSAY	HEPATITIS C ASSAY
7	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 333 CONEY ST. WALPOLE, MA 02032 US 914-524-2955 / 508-660-8540	ADVIA CENTAUR HEPATITIS C ASSAY	HEPATITIS C ASSAY
8	ST. PAUL BIOTECH 11555 MONARCH ST. GARDEN GROVE, CA 92841 US 714-903-1000 / 714-903-1000 226	MULTIPLE	HEPATITIS C VIRUS TEST
9	VIROTECH INTERNATIONAL, INC. 12 MEEM AVE., SUITE C GAITHERSBURG, MD 20877 US 301-924-8000 / 301-924-8000	HCV	HCV