VENOM TIME REAGENT; FDP COLLECTION TUBES 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	JCO
FDA Classification Name	BOTHROPS ATROX REAGENT
FDA Device Classification Code	Standards
FDA Regulation Number	864.8100
FDA Common Generic Name	VENOM TIME REAGENT; FDP COLLECTION TUBES
FDA Proprietary Device Name	VENOM TIME REAGENT; FDP COLLECTION TUBES
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	DADE BEHRING MARBURG GMBH 76 EMIL-VON-BEHRING STRASSE MARBURG, 35041 GM 847-267-5300 / 302-631-6311	BOTHROPS REAGENT	BOTHROPS REAGENT
2	DIAGNOSTICA STAGO 23/29 RUE CONSTANTIN PECQUER TAVERNY, 95150 FR 33-146-88 20 20 / 33-146-854851	STAR - REPTILASE	REAGENT FORT THE REPTILASE TIME TEST
3	DIAGNOSTICA-STAGO 2 RUE PIERRE FOSSATI FRANCONVILLE, 95130 FR 33-146-88 20 20 / 331-46-854851	STAR - REPTILASE	REAGENT FORT THE REPTILASE TIME TEST
4	DIAMED AG PRA ROND 23 CRESSIER SUR MORAT, CH 1785 SZ 412-667-45111x210 / 412-667-45111x210	DIAREPTIN	DIAREPTIN