HEMOSTASIS REFERENCE PLASMA; NORMAL COAGULATION CONTROL PLASMA MANUFACTURED BY TRINITY BIOTECH, PLC

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HEMOSTASIS REFERENCE PLASMA; NORMAL COAGULATION CONTROL PLASMA

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	GIZ
FDA Classification Name	PLASMA, CONTROL, NORMAL
FDA Device Classification Code	Standards
FDA Regulation Number	864.5425
FDA Common Generic Name	HRP; NCCP
FDA Proprietary Device Name	HEMOSTASIS REFERENCE PLASMA; NORMAL COAGULATION CONTROL PLASMA
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

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	NORMAL CONTROL PLASMA, PROTEIN S	NORMAL CONTROL PLASMA, PROTEIN S
2	ANALYTICAL CONTROL SYSTEMS, INC. 9058 TECHNOLOGY DR. FISHERS, IN 46038 US 317-841-0458 / 317-841-0458	CO-TROL	VARIOUS TYPE PLASMA, CONTROL NORMAL
3	BIO RESEARCH CANADA, INC. 6-255 SPINNAKER WAY CONCORD, ONTARIO, L4K 4J1 CA 905-760-0232 / 905-760-0232	MULTIPLE	VARIOUS
4	BIO/DATA CORP. 155 GIBRALTAR RD. HORSHAM, PA 19044 US 215-441-4000 / 215-441-4000	NORMAL REFERENCE PLASMA (VON WILLEBRAND FACTOR)	NORMAL CONTROL PLASMA
5	CHRONO-LOG CORP. 2 WEST PARK RD. HAVERTOWN, PA 19083 US 610-853-1130 / 610-853-1130	BIOPOOL HEMOSTASIS REFERENCE PLASMA, NORMAL	BIOPOOL HEMOSTASIS REFERENCE PLASMA, NORMAL
6	COMPLEX PHARMA, INC. 123 MILL ARBOUR LANE THORNHILL, ONTARIO, L4J 6M8 CA 416-568-7919 / 416-568-7919	PLASMA, CONTROL, NORMAL (MULTIPLE BRANDS)	PLASMA, CONTROL, NORMAL (MULTIPLE BRANDS)
7	CORGENIX, INC. 11575 MAIN ST. SUITE 400 BROOMFIELD, CO 80020 US 303-457-4345 / 303-457-4345 130	REAADS COAGULATION CONTROL 1	CONTROL PLASMAS
8	DADE BEHRING MARBURG GMBH 76 EMIL-VON-BEHRING STRASSE MARBURG, 35041 GM 847-267-5300 / 302-631-6311	CONTROL PLASMA N, STANDARD HUMAN PLASMA	CONTROL PLASMA, NORMAL
9	DIAGNOSTICA-STAGO 2 RUE PIERRE FOSSATI FRANCONVILLE, 95130 FR 33-146-88 20 20 / 331-46-854851	NO PROPRIETARY NAME LISTED	NO COMMON NAME LISTED
10	FISHER DIAGNOSTICS 8365 VALLEY PIKE MIDDLETOWN, VA 22645 US 412-490-8425 / 540-869-8163	PACIFIC HEMOSTASIS NORMAL COAGULATION CONTROL PLASMA	COAGULATION CONTROL, PLASMA, NORMAL
11	HEALTH CHEM DIAGNOSTICS LLC 3341 S.W. 15TH ST. POMPANO BEACH, FL 33069 US 954-979-3845 / 954-979-3845	PLASMA, CONTROL, NORMAL	PLASMA, CONTROL, NORMAL
12	HYPHEN BIOMED 155 RUE D' ERAGNY ZAC NEUVILLE-UNIVERSITE NEUVILLE SUR OISE, 95000 FR 33-1-34406510 / 33-1-34406510	BIOPHEN NORMAL CONTROL PLASMA	PLASMA CONTROL, NORMAL
13	INSTRUMENTATION LABORATORY CO. 526 RT. 303 ORANGEBURG, NY 10962 US 781-861-4467 / 781-861-4467	ASSAY REFERENCE PLASMA NORMAL	NORMAL REFERENCE PLASMA
14	PRECISION BIOLOGIC INC. 140 EILEEN STUBBS AVE DARTMOUTH, N.S., B3B 0A9 CA 902-468-6422 / 800-267-2796	CRYO-CHECK NORMAL HUMAN REFERENCE PLASMA	COAGULATION REFERENCE PLASMA
15	WORTHAM LABORATORIES INC 6340 BONNY OAKS DR. CHATTANOOGA, TN 37416 US 423-296-0090 / 423-296-0090	STASIS 1	NORMAL COAGULATION CONTROL

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