FTA ANTIGEN MANUFACTURED BY LEE LABORATORIES, INC.

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Request for Information Form	Contact Information
Company Name	LEE LABORATORIES, INC.
Address	1475 ATHENS HWY.
City, State, Zip	GRAYSON, GA 30017
Country	US
FDA Owner/Operator Phone	201-847-6800
FDA Medical Specialty Code	MI - Microbiology
FDA Product Code	JWL
FDA Classification Name	ANTIGEN, TREPONEMA PALLIDUM FOR FTA-ABS TEST
FDA Device Classification Code	Standards
FDA Regulation Number	866.3830
FDA Common Generic Name	FLUORESCENT TREPONEMAL ANTIBODY ANTIGEN
FDA Proprietary Device Name	FTA ANTIGEN
FDA Owner / Operator Number	9922032
FDA Owner / Operator Name	BECTON, DICKINSON & CO.
FDA Establishment Registration Number	1025402
FDA Registered Establishment Name	LEE LABORATORIES, INC.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	05-16-97
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 companies may manufacture a similar device.

	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	CENTERS FOR DISEASE CONTROL AND PREVENTION 1600 CLIFTON RD., N.E. ATLANTA, GA 30333 US / 404-639-3042	TREPONEMA PALLIDUM ANTIGEN SUSPENSION (FTA-ABS)	TREPONEMA PALLIDUM ANTIGEN SUSPENSION (FTA-ABS)
2	FUJIREBIO DIAGNOSTICS, INC. 201 GREAT VALLEY PKWY. MALVERN, PA 19355 US / 610-240-3829	OLYMPUS PK TP CONTROL SET	PK-TP CONTROL SET
3	FUJIREBIO DIAGNOSTICS, INC. 51 KOMIYA-CHO HACHIOJI-SHI TOKYO 192, JA / 610-240-3829	OLYMPUS PK TP REAGENT SYSTEM, OLYMPUS PKTP CONTROL SET	PK-TP REAGENT SYSTEM & CONTROLS
4	MARDX DIAGNOSTICS, INC. 5919 FARNSWORTH CT. CARLSBAD, CA 92008 US 353-127-69800 / 716-483-3851 1030	FTA-ABS/TREPONEMA PALLIDUM VARIOUS TEST SYSTEM	TREPONEMA PALLIDUM TEST SYSTEM/TREPONEMA PALLIDUM VARIOUS TEST SYSTEM
5	ZEUS SCIENTIFIC, INC. 200 EVANS WAY BRANCHBURG, NJ 08876 US 908-526-3744 / 908-243-4901	FLUORESCENT TREPONEMAL ANTIBODY ABSORBED TEST SYSTEM	FTA-ABS TEST SYSTEM