MULTIPLE MANUFACTURED BY ABBOTT LABORATORIES

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MULTIPLE

Request for Information Form	Contact Information
Company Name	ABBOTT LABORATORIES
Address	100 AND 200 ABBOTT PARK RD.
City, State, Zip	ABBOTT PARK, IL 60064
Country	US
FDA Owner/Operator Phone	847-937-6100
FDA Medical Specialty Code	MI - Microbiology
FDA Product Code	LOM
FDA Classification Name	TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)
FDA Device Classification Code	Premarket Approval
FDA Regulation Number	NULL
FDA Common Generic Name	ENZYME IMMUNOASSAYS FOR DIAGNOSIS & MONITORING OF HEPATITIS
FDA Proprietary Device Name	MULTIPLE
FDA Owner / Operator Number	1415939
FDA Owner / Operator Name	ABBOTT LABORATORIES
FDA Establishment Registration Number	1415939
FDA Registered Establishment Name	ABBOTT LABORATORIES
FDA Operation Code(s)	MM - Manufacturer MS - Specification Developer
FDA Listing Date	10-07-97
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of ABBOTT LABORATORIES

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 DIAGNOSTICS INTERNATIONAL, LTD. KM 58.0, CARRETERA 2 CRUCE DAVILA BARCELONETA, PR 00617 US 847-937-6100 / 847-938-3471	MULTIPLE	ENZYME IMMUNOASSAY
2	ABBOTT MOLECULAR, INC. 1300 EAST TOUHY AVENUE DES PLAINES, IL 60018 US 847-937-6100 / 847-938-3471	ABBOTT REALTIME HBV	IN VITRO PCR ASSAY QUANTITATION OF HBV
3	BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. CHASKA, MN 55318 US 714-871-4848 / 714-993-5321 8383	ACCESS HBC IGM	HEPATITIS ASSAYS
4	BINAX, INC. 10 SOUTHGATE RD. SCARBOROUGH, ME 04074 US 781-674-3900 / 207-730-5740	BINAX NOW ICT HEPATITIS B SAG/EAG	HEPATITIS B RAPID TEST, HEPATITIS B ICT TEST
5	BIOMERIEUX BV BOSEIND 15 BOXTEL, 5280 AB NL 33-478-872063 / 314-731-8594	CONFIRMATION OF HBE AG/ANTIHBE MICROELISA SYSTEM	HEPANOSTIKA HBE AG/ANTIHBE MICROELISA SYSTEM
6	DIASORIN S.P.A. VIA CRESCENTINO SALUGGIA (VC), 13040 IT 390-161-487 093 / 651-351-5820	MULTIPLE	VARIOUS
7	GLOBALEMED, LLC 1101 KING STREET SUITES 370/270/170 ALEXANDRIA, VA 22314 US 703-894-0710 / 703-894-0710 218	HBV MULTIPLE DIAGNOSIS PRODUCTS	HBV MULTIPLE DIAGNOSIS PRODUCTS
8	IMMUNOSCIENCE, INC. 7066-D COMMERCE CIR. PLEASANTON, CA 94588 US / 925-460-8111	SALIVAX	COLLOIDAL GOLD RAPID IMMUNOASSAY FOR HEPATITIS B
9	ORTHO-CLINICAL DIAGNOSTICS FOREST FARM ESTATE WHITCHURCH CARDIFF, CF14 7YT UK 585-453-4469 / 585-453-4152	VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK AND CALIBRATORS	TOTAL ANTIBODY TO HEPATITIS B SURFACE ANTIGEN ASSAY
10	ROCHE DIAGNOSTICS GMBH NONNENWALD 2 PENZBERG, D-82377 GM 49-621-7670 / 317-521-2834	ELECSYS HBSAG ASSAY	HEPATITIS B SURFACE ANTIGEN ASSAY
11	ROCHE DIAGNOSTICS GMBH SANDHOFER STRASSE 116 MANNHEIM, D-68298 GM 49-621-7670 / 317-521-2834	ELECSYS H BS AG IMNUNOASSAY	ELECTROCHENULUNINESCENCE ASSAY FOR DETERMINATION OF HEPATITIS BS AG
12	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5210 PACIFIC CONCOURSE DR. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955	IMMULITE/IML 2000 HEPATITIS B SURFACE ANTIGEN (HBSAG)	IMMUNOASSAY DESIGNED FOR DETECTION OF HBSAG IN HUMANS
13	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5700 WEST 96TH ST. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955	IMMULITE/ IML 2000 HEPATITIS B SURFACE ANTIGEN (HBSAG)	IMMUNOASSAY DESIGNED FOR DETECTION OF HBSAG IN HUMANS
14	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 BENEDICT AVENUE TARRYTOWN, NY 10591 US 914-524-2955 / 914-524-2955	ADVIA CENTAUR HEPATITIS B ASSAYS	HEPATITIS ASSAYS
15	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 333 CONEY ST. WALPOLE, MA 02032 US 914-524-2955 / 508-660-8540	ADVIA CENTAUR HEPATITIS B ASSAYS	HEPATITIS ASSAYS
16	ST. PAUL BIOTECH 11555 MONARCH ST. GARDEN GROVE, CA 92841 US 714-903-1000 / 714-903-1000 226	MULTIPLE	HEPATITIS B TEST