MULTIPLE MANUFACTURED BY HELENA LABORATORIES

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Request for Information Form	Contact Information
Company Name	HELENA LABORATORIES
Address	1530 LINDBERGH DR.
City, State, Zip	BEAUMONT, TX 77704
Country	US
FDA Owner/Operator Phone	409-842-3714
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	CK ISOENZYME DETERMINATION
FDA Proprietary Device Name	MULTIPLE
FDA Owner / Operator Number	1618982
FDA Owner / Operator Name	HELENA LABORATORIES
FDA Establishment Registration Number	1618982
FDA Registered Establishment Name	HELENA LABORATORIES
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	06-27-06
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 DIAGNOSTICS INTERNATIONAL, LTD. KM 58.0, CARRETERA 2 CRUCE DAVILA BARCELONETA, PR 00617 US 847-937-6100 / 847-938-3471	IMX STAT 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	IMX STAT CK-MB	ASSAY FOR DETECTION OF CREATINE KINASE
3	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
4	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
5	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
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