IMX STAT 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	JHY
FDA Classification Name	COLORIMETRIC METHOD, CPK OR 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	IMX STAT 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	IMX STAT CK-MB	ASSAY FOR DETECTION OF CREATINE KINASE
2	BIOSITE INCORPORATED 9975 SUMMERS RIDGE RD SAN DIEGO, CA 92121 US 781-674-3900 / 858-805-3423	TRIAGE CARDIC PANEL	FLUORESCENCEI IMMUNOASSAY FOR CK-MB, TROPONIN I AND MYOGLOBIN
3	DADE BEHRING, INC. 500 GBC DR, MAILSTOP 514 NEWARK, DE 19714 US 847-267-5300 / 302-631-6311	MULTIPLE	VARIOUS MASS CREATINE KINASE ISONEZYME METHODS
4	HEALTH CHEM DIAGNOSTICS LLC 3341 S.W. 15TH ST. POMPANO BEACH, FL 33069 US 954-979-3845 / 954-979-3845	COLORIMETRIC METHOD, CPK OR ISOENZYMES	COLORIMETRIC METHOD, CPK OR ISOENZYMES
5	HELENA LABORATORIES 1530 LINDBERGH DR. BEAUMONT, TX 77704 US 409-842-3714 / 409-842-3714 271	MULTIPLE	CK ISOENZYME DETERMINATION
6	MYERS-STEVENS GROUP 2931 VAIL AVE. COMMERCE, CA 90040 US 323-721-8552 / 903-566-6696	TARGET(TM) CK-MB	EIA TEST FOR THE QUANTITATION OF CPK-MB