CHROM Z HEPARIN MANUFACTURED BY HELENA LABORATORIES

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CHROM Z HEPARIN

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	HE - Hematology
FDA Product Code	KFF
FDA Classification Name	ASSAY, HEPARIN
FDA Device Classification Code	Standards
FDA Regulation Number	864.7525
FDA Common Generic Name	HEPARIN DIAGNOSTIC KIT
FDA Proprietary Device Name	CHROM Z HEPARIN
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	09-07-06
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of HELENA LABORATORIES

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	AMERICAN DIAGNOSTICA, INC. 500 WEST AVENUE STAMFORD, CT 06902 US 203-602-7777 / 203-602-7777	ACTICHOME ACTIVITY KIT	HEPARIN ASSAY
2	DADE BEHRING MARBURG GMBH 76 EMIL-VON-BEHRING STRASSE MARBURG, 35041 GM 847-267-5300 / 302-631-6311	BERICHROM HEPARIN	HEPARIN ASSAY
3	DIAGNOSTICA STAGO 23/29 RUE CONSTANTIN PECQUER TAVERNY, 95150 FR 33-146-88 20 20 / 33-146-854851	MULTIPLE	VARIOUS
4	DIAGNOSTICA-STAGO 2 RUE PIERRE FOSSATI FRANCONVILLE, 95130 FR 33-146-88 20 20 / 331-46-854851	MULTIPLE	VARIOUS
5	HAEMACHEM, INC. 2335 SOUTH HANLEY RD. ST. LOUIS, MO 63144 US 314-644-3277 / 314-644-3277	HEPTEST	HEPARIN ASSAY
6	HEPTEST LABORATORIES, INC. 1431 HANLEY INDUSTRIAL COURT ST. LOUIS, MO 63144 US 314-962-3527 / 314-962-3527	HEPTEST	HEPARIN ASSAY
7	HYPHEN BIOMED 155 RUE D' ERAGNY ZAC NEUVILLE-UNIVERSITE NEUVILLE SUR OISE, 95000 FR 33-1-34406510 / 33-1-34406510	BIOPHEN HEPARIN 3 AND 6	HEPARIN ASSAY
8	INSTRUMENTATION LABORATORY CO. 526 RT. 303 ORANGEBURG, NY 10962 US 781-861-4467 / 781-861-4467	MULTIPLE: HEMOSIL HEPARIN, COAMATIC HEPARIN, ETC.	HEPARIN ASSAY
9	INTERNATIONAL TECHNIDYNE CORP. 23 NEVSKY ST. EDISON, NJ 08820 US 732-548-5700 / 732-548-5700 265	HEMOCHRON TXDX HRT/PRT TESTS, VARIOUS; TDA TESTS, VARIOUS	HEPARIN RESPONSE TESTS, VARIOUS
10	INTERNATIONAL TECHNIDYNE CORPORATION 20 CORPORATE PLACE SOUTH PISCATAWAY, NJ 08854 US 732-548-5700 / 732-548-5700 265	HEMOCHRON WHOLE BLOOD COAGULATION ASSAY	HEPARIN RESPONSE TEST, VARIOUS
11	INTERNATIONAL TECHNIDYNE CORPORATION 330 TALMADGE RD. EDISON, NJ 08820 US 732-548-5700 / 732-548-5700 265	HEMOCHRON WHOLE BLOOD COAGULATION ASSAY	HEPARIN RESPONSE TEST, VARIOUS
12	TRINITY BIOTECH, PLC IDA BUSINESS PARK BRAY CO. WICKLOW, EI 353-127-69800 / 35-31-2769800	MDA HEPARIN ANTI-XA, BIOMERIEUX HEPARIN ANTI-XA	MDA HEPARIN ANTI-XA, BIOMERIEUX HEPARIN ANTI-XA