MDA HEPARIN ANTI-XA, BIOMERIEUX HEPARIN ANTI-XA MANUFACTURED BY TRINITY BIOTECH, PLC

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MDA HEPARIN ANTI-XA, BIOMERIEUX HEPARIN ANTI-XA

Request for Information Form	Contact Information
Company Name	TRINITY BIOTECH, PLC
Address	IDA BUSINESS PARK BRAY
City, State, Zip	CO. WICKLOW,
Country	EI
FDA Owner/Operator Phone	353-127-69800
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	MDA HEPARIN ANTI-XA, BIOMERIEUX HEPARIN ANTI-XA
FDA Proprietary Device Name	MDA HEPARIN ANTI-XA, BIOMERIEUX HEPARIN ANTI-XA
FDA Owner / Operator Number	9025161
FDA Owner / Operator Name	TRINITY BIOTECH, PLC
FDA Establishment Registration Number	9681576
FDA Registered Establishment Name	TRINITY BIOTECH, PLC
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	05-30-07
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of TRINITY BIOTECH, PLC

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	HELENA LABORATORIES 1530 LINDBERGH DR. BEAUMONT, TX 77704 US 409-842-3714 / 409-842-3714 271	CHROM Z HEPARIN	HEPARIN DIAGNOSTIC KIT
7	HEPTEST LABORATORIES, INC. 1431 HANLEY INDUSTRIAL COURT ST. LOUIS, MO 63144 US 314-962-3527 / 314-962-3527	HEPTEST	HEPARIN ASSAY
8	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
9	INSTRUMENTATION LABORATORY CO. 526 RT. 303 ORANGEBURG, NY 10962 US 781-861-4467 / 781-861-4467	MULTIPLE: HEMOSIL HEPARIN, COAMATIC HEPARIN, ETC.	HEPARIN ASSAY
10	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
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	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