ANTI-TISSUE TRANSGLUTAMINASE IGA ELISA TEST RTA4000 MANUFACTURED BY BIOFONS, LTD.

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ANTI-TISSUE TRANSGLUTAMINASE IGA ELISA TEST RTA4000

Request for Information Form	Contact Information
Company Name	BIOFONS, LTD.
Address	TYKISTOKATU 4 B
City, State, Zip	TURKU,
Country	FI
FDA Owner/Operator Phone	358-201-552121
FDA Medical Specialty Code	IM - Immunology
FDA Product Code	MVM
FDA Classification Name	AUTOANTIBODIES, ENDOMYSIAL(TISSUE TRANSGLUTAMINASE)
FDA Device Classification Code	Standards
FDA Regulation Number	866.5660
FDA Common Generic Name	ANTI-TISSUE TRANSGLUTAMINASE IGA ELISA TEST
FDA Proprietary Device Name	ANTI-TISSUE TRANSGLUTAMINASE IGA ELISA TEST RTA4000
FDA Owner / Operator Number	9052645
FDA Owner / Operator Name	BIOFONS, LTD.
FDA Establishment Registration Number	3003889346
FDA Registered Establishment Name	BIOFONS, LTD.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	08-13-02
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

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1	AESKU.DIAGNOSTICS MIKROFORUM RING 2 WENDELSHEIM, D-55234 GM 49-673-496270 / 678-491-4612	AESKULISA, MULTIPLE	MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM
2	BIOMEDICAL DIAGNOSTICS (BMD) SA ACTIPOLE 25 4-6 BLD DE BEAUBOURG MARNE LA VALLEE CEDEX 2, 77435 FR 33-164-621012 / 33-166-621012	FIDIS TM CELIAC	IMMUNOLOGICAL TESTING
3	EUROIMMUN US LLC 429 ROCKAWAY VALLEY RD. UNIT 1200 BOONTON, NJ 07005 US 973-402-6101 / 973-402-6101	EUROIMMUN EMA KIT	EMA KIT
4	EUROSPITAL S.P.A. VIA FLAVIA 122 TRIESTE, 1-34147 IT 003-904-089971 / 978-927-3808	EU-TTT IGA	ENZYME IMMUNOASSAY FOR DETECTION OF IGA ANTIBODIES AGAINST TISSUE TRANSGLUTAMINA
5	HYCOR BIOMEDICAL LTD. PENTLANDS SCIENCE PARK BUSH LOAN EDINBURGH, EH26 OPL UK 44-131-445 7111 / 44-131-445 7111	AUTOSTAT TM II ANTI-TISSUE TRANSGLUTAMINASE IGA ELISA	AUTOSTAT TM II ANTI-TTG IGA ELISA
6	IMMCO DIAGNOSTICS, INC. 60 PINEVIEW DR. BUFFALO, NY 14228 US 716-691-0091 / 716-691-0091	IMMCO DIAGNOSTICS IMMUGLO ANTI RETICULIN ARA ANTIBODY ASSAY	ANTI RETICULIN ARA ANTIBODY
7	INOVA DIAGNOSTICS, INC. 9900 OLD GROVE RD. SAN DIEGO, CA 92131 US 858-586-9900 / 858-586-9900 351	QUANTA LITE	TISSUE TRANSGLUTAMINASE ELISA
8	MARDX DIAGNOSTICS, INC. 5919 FARNSWORTH CT. CARLSBAD, CA 92008 US 353-127-69800 / 716-483-3851 1030	ENDOMYSIUM IFA TEST SYSTEM	ENDOMYSIUM IFA TEST SYSTEM
9	MEDICA, INC. 336 ENCINITAS BLVD., SUITE 200 ENCINITAS, CA 92024 US 760-634-5440 / 760-634-5440	MEDICA INDIRECT IMMUNOFLUORESCENCE (IIF) ANTI ENDOMYSIAL ANTIBODY (AEMA) TESTKIT	INDIRECT IMMUNOFLUORESCENCE ANTI ENDOMYSIAL ANTIBODY TEST KIT
10	PHADIA AB RAPSGATAN 7 UPPSALA, SE-754 50 SW 46-18-165000 / 46-18-163775	MULTIPLE	AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM
11	PHADIA GMBH MUNZINGER STRASSE 7 FREIBURG, D-79111 GM 46-18-165000 / 49-761-47805-278	MULTIPLE	AUTOANTIBODIES, ENDOMYSIAL (TISSUE TRANSGLUTAMINASE)
12	THE BINDING SITE BUILDING A WARSTOCK ROAD, KINGS HEATH BIRMINGHAM, B14 4RT UK 44-121-4361000 / 44-1-214361000	ANTI-TRANSGLUTAMINASE EIA KIT	ANTI-TRANSGLUTAMINASE EIA KIT