NMP22 BLADDERCHECK TEST MANUFACTURED BY BRITISH BIOCELL INTERNATIONAL LTD

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Request for Information Form	Contact Information
Company Name	BRITISH BIOCELL INTERNATIONAL LTD
Address	GOLDEN GATE, TY GLAS AVENUE
City, State, Zip	CARDIFF,
Country	UK
FDA Owner/Operator Phone	44-292-0747232
FDA Medical Specialty Code	IM - Immunology
FDA Product Code	MMW
FDA Classification Name	SYSTEM, TEST, TUMOR MARKER, MONITORING, BLADDER
FDA Device Classification Code	Standards
FDA Regulation Number	866.6010
FDA Common Generic Name	BLADDER TUMOR ANTIGEN TEST
FDA Proprietary Device Name	NMP22 BLADDERCHECK TEST
FDA Owner / Operator Number	9094899
FDA Owner / Operator Name	BRITISH BIOCELL INTERNATIONAL LTD
FDA Establishment Registration Number	122316
FDA Registered Establishment Name	BRITISH BIOCELL INTERNATIONAL LTD
FDA Operation Code(s)	ME - Contract Manufacturer
FDA Listing Date	05-24-07
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	ABBOTT MOLECULAR, INC. 1300 EAST TOUHY AVENUE DES PLAINES, IL 60018 US 847-937-6100 / 847-938-3471	UROVYSION BLADDER CANCER KIT	FLUORESCENCE IN SITU HYBRIDIZATION (FISH) REAGENTS
2	DIAGNOCURE, INC. 2050 BOUL. RENE'-LEVESQUE W., 6TH FLOOR, STE-FOY QUEBEC, G1V 2K8 CA 418-527-6100 / 418-527-6100 x227	IMMUNOCYT	IMMUNOHISTOCHEMISTRY KIT
3	MATRITECH, INC. 330 NEVADA ST., 2ND FL. NEWTON, MA 02460 US 617-928-0820 / 617-658-5246	NMP22 BLADDERCHEK KIT	NMP22 BLADDERCHEK KIT
4	POLYMEDCO, INC. 510 FURNACE DOCK ROAD CORTLANDT MANOR, NY 10567 US 914-739-5400 / 206-262-7363	BTA STAT TEST PRESCRIPTION HOME USE	BLADDER TUMOR ANTIGEN