ELECSYS HBSAG ASSAY MANUFACTURED BY ROCHE DIAGNOSTICS GMBH

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ELECSYS HBSAG ASSAY

Request for Information Form	Contact Information
Company Name	ROCHE DIAGNOSTICS GMBH
Address	NONNENWALD 2
City, State, Zip	PENZBERG,
Country	GM
FDA Owner/Operator Phone	49-621-7670
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	HEPATITIS B SURFACE ANTIGEN ASSAY
FDA Proprietary Device Name	ELECSYS HBSAG ASSAY
FDA Owner / Operator Number	9036646
FDA Owner / Operator Name	ROCHE DIAGNOSTICS GMBH MANNHEIM
FDA Establishment Registration Number	9610529
FDA Registered Establishment Name	ROCHE DIAGNOSTICS GMBH
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	05-07-01
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of ROCHE DIAGNOSTICS GMBH

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 LABORATORIES 100 AND 200 ABBOTT PARK RD. ABBOTT PARK, IL 60064 US 847-937-6100 / 847-938-3471	MULTIPLE	ENZYME IMMUNOASSAYS FOR DIAGNOSIS & MONITORING OF HEPATITIS
3	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
4	BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. CHASKA, MN 55318 US 714-871-4848 / 714-993-5321 8383	ACCESS HBC IGM	HEPATITIS ASSAYS
5	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
6	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
7	DIASORIN S.P.A. VIA CRESCENTINO SALUGGIA (VC), 13040 IT 390-161-487 093 / 651-351-5820	MULTIPLE	VARIOUS
8	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
9	IMMUNOSCIENCE, INC. 7066-D COMMERCE CIR. PLEASANTON, CA 94588 US / 925-460-8111	SALIVAX	COLLOIDAL GOLD RAPID IMMUNOASSAY FOR HEPATITIS B
10	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
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 333 CONEY ST. WALPOLE, MA 02032 US 914-524-2955 / 508-660-8540	ADVIA CENTAUR HEPATITIS B ASSAYS	HEPATITIS ASSAYS
13	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 BENEDICT AVENUE TARRYTOWN, NY 10591 US 914-524-2955 / 914-524-2955	ADVIA CENTAUR HEPATITIS B ASSAYS	HEPATITIS ASSAYS
14	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
15	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
16	ST. PAUL BIOTECH 11555 MONARCH ST. GARDEN GROVE, CA 92841 US 714-903-1000 / 714-903-1000 226	MULTIPLE	HEPATITIS B TEST