GLUCOSE-6-PHOSPHATE DEHYDROGENASE (ERYTHROCYTIC), SCREENING MANUFACTURED BY HEALTH CHEM DIAGNOSTICS LLC

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Request for Information Form	Contact Information
Company Name	HEALTH CHEM DIAGNOSTICS LLC
Address	3341 S.W. 15TH ST.
City, State, Zip	POMPANO BEACH, FL 33069
Country	US
FDA Owner/Operator Phone	954-979-3845
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	GLUCOSE-6-PHOSPHATE DEHYDROGENASE (ERYTHROCYTIC), SCREENING
FDA Owner / Operator Number	9060349
FDA Owner / Operator Name	HEALTH CHEM DIAGNOSTICS LLC
FDA Establishment Registration Number	1048532
FDA Registered Establishment Name	HEALTH CHEM DIAGNOSTICS LLC
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	05-09-97
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	TRINITY BIOTECH, PLC IDA BUSINESS PARK BRAY CO. WICKLOW, EI 353-127-69800 / 35-31-2769800	G-6-PDH SCREENING TEST KIT	GLUCOSE-6-PHOSPHATE DEHYDROGENASE (ERYTHROCYTIC), SCREENING