AXSYSM CK-MB 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	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	ASSAY FOR DETECTION OF CREATINE KINASE
FDA Proprietary Device Name	AXSYSM CK-MB
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	12-01-00
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	AXSYSM CK-MB	ASSAY FOR DETECTION OF CREATINE KINASE
2	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
3	BECKMAN COULTER, INC. (IRELAND) MERVUE BUSINESS PARK GALWAY, EI 714-871-4848 / 714-993-8383	MULTIPLE	CK REAGENT
4	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
5	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
6	HELENA LABORATORIES 1530 LINDBERGH DR. BEAUMONT, TX 77704 US 409-842-3714 / 409-842-3714 271	NO PROPRIETARY NAME LISTED	NO COMMON NAME LISTED
7	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
8	ROCHE DIAGNOSTICS GMBH NONNENWALD 2 PENZBERG, D-82377 GM 49-621-7670 / 317-521-2834	ELECSYS CK-MB STAT	CK-MB ASSAY
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