ELECSYS CK-MB STAT MANUFACTURED BY ROCHE DIAGNOSTICS GMBH

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ELECSYS CK-MB STAT

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	CH - Clinical Chemistry
FDA Product Code	JHW
FDA Classification Name	U.V. METHOD, CPK ISOENZYMES
FDA Device Classification Code	Standards
FDA Regulation Number	862.1215
FDA Common Generic Name	CK-MB ASSAY
FDA Proprietary Device Name	ELECSYS CK-MB STAT
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	AXSYSM CK-MB	ASSAY FOR DETECTION OF CREATINE KINASE
2	ABBOTT LABORATORIES 100 AND 200 ABBOTT PARK RD. ABBOTT PARK, IL 60064 US 847-937-6100 / 847-938-3471	AXSYSM CK-MB	ASSAY FOR DETECTION OF CREATINE KINASE
3	BECKMAN COULTER, INC. 2470 FARADAY AVE. CARLSBAD, CA 92008 US 714-871-4848 / 714-993-5321 8383	DRI-STAT CK-MB REAGENT	CREATINE PHOSPHOKINASE ISOENZYMES ANALYSIS PRODUCT
4	BECKMAN COULTER, INC. (IRELAND) MERVUE BUSINESS PARK GALWAY, EI 714-871-4848 / 714-993-8383	MULTIPLE	CK REAGENT
5	GELMAN SCIENCES INC., A WHOLLY OWNED SUBSIDIARY OF 600 SOUTH WAGNER RD. ANN ARBOR, MI 48103 US 734-665-0651 / 734-665-0651 6134	CPK;UV REAGENT SET	ELECTROPHORESIS REAGENTS AND CONTROLS
6	HEALTH CHEM DIAGNOSTICS LLC 3341 S.W. 15TH ST. POMPANO BEACH, FL 33069 US 954-979-3845 / 954-979-3845	U.V. METHOD, CPK ISOENZYMES	U.V. METHOD, CPK ISOENZYMES
7	HELENA LABORATORIES 1530 LINDBERGH DR. BEAUMONT, TX 77704 US 409-842-3714 / 409-842-3714 271	NO PROPRIETARY NAME LISTED	NO COMMON NAME LISTED
8	REAGENTS APPLICATIONS, INC. 8225 MERCURY CT. SAN DIEGO, CA 92111 US 800-436-2436 / 443-367-5501	RAICHEM	REAGENT FOR THE MEASUREMENT OF CREATINE KINASE-MB ACTIVITY
9	WIENER LABORATORIOS S.A.I.C. 2571 MAIPU ROSARIO SANTA FE, 2000 AR 011-543-414851982 / 011-543-414851982	CK MB DS VV & CK MB NAC VV	TEST SYSTEM TO MEASURE THE ACTIVITY OF CPK/CK OR ISOENZYMES