G-6-PDH SCREENING TEST KIT 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	JBF
FDA Classification Name	GLUCOSE-6-PHOSPHATE DEHYDROGENASE (ERYTHROCYTIC), SCREENING
FDA Device Classification Code	Standards
FDA Regulation Number	864.7360
FDA Common Generic Name	GLUCOSE-6-PHOSPHATE DEHYDROGENASE (ERYTHROCYTIC), SCREENING
FDA Proprietary Device Name	G-6-PDH SCREENING TEST KIT
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	09-08-03
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 companyies may manufacture a similar device.

	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	HEALTH CHEM DIAGNOSTICS LLC 3341 S.W. 15TH ST. POMPANO BEACH, FL 33069 US 954-979-3845 / 954-979-3845	GLUCOSE-6-PHOSPHATE DEHYDROGENASE (ERYTHROCYTIC), SCREENING	GLUCOSE-6-PHOSPHATE DEHYDROGENASE (ERYTHROCYTIC), SCREENING