OLYMPUS PK TP CONTROL SET MANUFACTURED BY FUJIREBIO DIAGNOSTICS, INC.

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Request for Information Form	Contact Information
Company Name	FUJIREBIO DIAGNOSTICS, INC.
Address	201 GREAT VALLEY PKWY.
City, State, Zip	MALVERN, PA 19355
Country	US
FDA Owner/Operator Phone	--
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	PK-TP CONTROL SET
FDA Proprietary Device Name	OLYMPUS PK TP CONTROL SET
FDA Owner / Operator Number	8031611
FDA Owner / Operator Name	FUJIREBIO DIAGNOSTICS, INC.
FDA Establishment Registration Number	2521625
FDA Registered Establishment Name	FUJIREBIO DIAGNOSTICS, INC.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	08-31-04
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. 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
3	LEE LABORATORIES, INC. 1475 ATHENS HWY. GRAYSON, GA 30017 US 201-847-6800 / 410-316-4000 4099	FTA ANTIGEN	FLUORESCENT TREPONEMAL ANTIBODY ANTIGEN
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