RISTOCETIN; PLATELET AGGREGATION REAGENTS MANUFACTURED BY TRINITY BIOTECH, PLC

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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	GHR
FDA Classification Name	REAGENT, PLATELET AGGREGATION
FDA Device Classification Code	Standards
FDA Regulation Number	864.5700
FDA Common Generic Name	RISTOCETIN; PLATELET AGGREGATION REAGENTS
FDA Proprietary Device Name	RISTOCETIN; PLATELET AGGREGATION REAGENTS
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	02-03-03
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	BIO/DATA CORP. 155 GIBRALTAR RD. HORSHAM, PA 19044 US 215-441-4000 / 215-441-4000	BETA PAK; ADP; RISTOCETIN; EPINEPHRINE	PLATELET AGGREGATION REAGENTS (COLLAGEN, EPINEPHRINE, RISTOCETIN)
2	CHRONO-LOG CORP. 2 WEST PARK RD. HAVERTOWN, PA 19083 US 610-853-1130 / 610-853-1130	CHRONO-PAR KIT	REAGENTS PLATELET AGGREGATION
3	DADE BEHRING MARBURG GMBH 76 EMIL-VON-BEHRING STRASSE MARBURG, 35041 GM 847-267-5300 / 302-631-6311	PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE,ADP CARTRIDGE & PFA TRIGGER SOLUTION	PLATELET FUNCTION
4	DIAGNOSTICA-STAGO 2 RUE PIERRE FOSSATI FRANCONVILLE, 95130 FR 33-146-88 20 20 / 331-46-854851	AGGREGATEST	PLATELET AGGREGATION REAGENTS
5	HELENA LABORATORIES 1530 LINDBERGH DR. BEAUMONT, TX 77704 US 409-842-3714 / 409-842-3714 271	MULTIPLE	PLATELET AGGREGATION REAGENTS