BORRELIA B31 IGM/IGG VIRABLOT MANUFACTURED BY VIRAMED BIOTECH AG

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BORRELIA B31 IGM/IGG VIRABLOT

Request for Information Form	Contact Information
Company Name	VIRAMED BIOTECH AG
Address	BEHRINGSTRASSE 11
City, State, Zip	PLANEGG,
Country	GM
FDA Owner/Operator Phone	011-49-89899336
FDA Medical Specialty Code	MI - Microbiology
FDA Product Code	LSR
FDA Classification Name	REAGENT, BORRELIA SEROLOGICAL REAGENT
FDA Device Classification Code	Standards
FDA Regulation Number	866.3830
FDA Common Generic Name	BORRELIA BURGDORFERI IGM/IGG WESTERN BLOT
FDA Proprietary Device Name	BORRELIA B31 IGM/IGG VIRABLOT
FDA Owner / Operator Number	9062838
FDA Owner / Operator Name	VIRAMED BIOTECH AG
FDA Establishment Registration Number	3004181478
FDA Registered Establishment Name	VIRAMED BIOTECH AG
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	09-06-05
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of VIRAMED BIOTECH AG

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	BBI DIAGNOSTICS, A DIVISION OF SERACARE LIFE SCIEN 375 WEST ST. WEST BRIDGEWATER, MA 02379 US 508-580-1900 / 508-580-1900 2175	REAGENT, BORRELIA SEROLOGICAL REAGENT	VARIOUS
2	BIOMERIEUX SA CHEMIN DE L'ORME MARCY L'ETOILE, 69280 FR 33-478-872063 / 314-731-8594	VIDAS LYME SCREEN II IGGD IGM ASSAY	ENZY-LINKED FLUORESCENT IMMUNOASSAY (ELFA) FOR LYME IG GD IGM
3	BIOMERIEUX, INC. 595 ANGLUM RD. HAZELWOOD, MO 63042 US 33-478-872063 / 314-731-8594	VIDAS LYME SCREEN II IGGD IGM ASSAY	ENZY-LINKED FLUORESCENT IMMUNOASSAY (ELFA) FOR LYME IG GD IGM
4	BION ENTERPRISES, LTD. 455 STATE STREET, SUITE 100 DES PLAINES, IL 60016 US 847-544-5044 / 847-544-5044	BORRELIA BURGDORFERI SUBSTRATE FOR LYME DISEASE	BORRELIA BURGDORFERI SUBSTRATE SLIDE
5	CHEMBIO DIAGNOSTIC SYSTEMS, INC. 3661 HORSEBLOCK RD. MEDFORD, NY 11763 US 631-924-1135 / 631-924-1135	PREVUE BORRELIA BURGDORFERI ANTIBODY DETECTION TEST	LYME TEST
6	DIAMEDIX CORP. 2140 NORTH MIAMI AVE. MIAMI, FL 33127 US 305-324-2300 / 305-324-2354	IS-ANTI B. DURGDORFERI IQG/IQM ELISA KITS	BORRELIA ELISA TEST
7	GENBIO 15222 AVE. OF SCIENCE, SUITE A SAN DIEGO, CA 92128 US 858-592-9300 309 / 858-592-9300 309	IMMUNOWELL BORRELIA (LYME) TEST	IMMUNOWELL BORRELIA (LYME) PANEL (IGG & IGM COMBINED)
8	GLOBALEMED, LLC 1101 KING STREET SUITES 370/270/170 ALEXANDRIA, VA 22314 US 703-894-0710 / 703-894-0710 218	PREVUE (TM) BORRELIA BURGDOR MULTIPLE DIAGNOSIS PRODUCTS	PREVUE (TM) BORRELIA BURGDOR MULTIPLE DIAGNOSIS PRODUCTS
9	IMMUNETICS, INC. 27 DRYDOCK AVE. 6TH FLOOR BOSTON, MA 02210 US 617-896-9100 / 617-896-9100	MULTIPLE	LYME ELISA, LYME IGG WESTERN BLOT, LYME IGM WESTERN BLOT
10	MARDX DIAGNOSTICS, INC. 5919 FARNSWORTH CT. CARLSBAD, CA 92008 US 353-127-69800 / 716-483-3851 1030	BORRELIA BURGDORFERI ELISA/MARBLOT TEST SYSTEMSAND MULTIPLE	LYME IFA/EIA KIT & LYME TEST SYSTEM MULTIPLE/VARIOUS COMPONENTS
11	MERIDIAN BIOSCIENCE, INC. 3471 RIVER HILLS DR. CINCINNATI, OH 45244 US 513-271-3700 / 513-271-3700 229	MULTIPLE: PREMIER LYME IGM AND PREMIER HUMAN LYME	VARIOUS EIAS FOR THE DETECTION OF LYME DISEASE
12	REMEL ATLANTA, A DIV. OF REMEL, INC. 2797 PETERSON PL. NORCROSS, GA 30071 US 412-490-8425 / 412-490-8425	MULTIPLE	VARIOUS BORRELIA SEROLOGICAL REAGENTS
13	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5700 WEST 96TH ST. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955	I.D. BLOT BORRELIA IGG	IDENTIFY BORRELIA SPECIFIC IGG IN HUMAN SERUM BY IMMUNOCHEMICAL MEANS
14	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5210 PACIFIC CONCOURSE DR. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955	I.D. BLOT BORRELIA IGG	IDENTIFY BORRELIA SPECIFIC IGG IN HUMAN SERUM BY IMMUNOCHEMICAL MEANS
15	TRINITY BIOTECH USA 2823 GIRTS RD. JAMESTOWN, NY 14701 US 353-127-69800 / 716-483-3851	MULTIPLE	VARIOUS TYPES OF BORRELIA BERGDORFERI EIA TEST KITS
16	ZEUS SCIENTIFIC, INC. 200 EVANS WAY BRANCHBURG, NJ 08876 US 908-526-3744 / 908-243-4901	B. BURGDORFERI (LYME) ELISA TEST SYSTEM	B. BURGDORFERI (LYME) ELISA TEST SYSTEM

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