I.D. BLOT BORRELIA IGG MANUFACTURED BY SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS

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I.D. BLOT BORRELIA IGG

Request for Information Form	Contact Information
Company Name	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
Address	5210 PACIFIC CONCOURSE DR.
City, State, Zip	LOS ANGELES, CA 90045
Country	US
FDA Owner/Operator Phone	914-524-2955
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	IDENTIFY BORRELIA SPECIFIC IGG IN HUMAN SERUM BY IMMUNOCHEMICAL MEANS
FDA Proprietary Device Name	I.D. BLOT BORRELIA IGG
FDA Owner / Operator Number	9096044
FDA Owner / Operator Name	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
FDA Establishment Registration Number	3005250747
FDA Registered Establishment Name	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
FDA Operation Code(s)	MM - Manufacturer MS - Specification Developer
FDA Listing Date	04-07-05
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS

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	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
15	VIRAMED BIOTECH AG BEHRINGSTRASSE 11 PLANEGG, D-82152 GM 011-49-89899336 / 760-594-7285	BORRELIA B31 IGM/IGG VIRABLOT	BORRELIA BURGDORFERI IGM/IGG WESTERN BLOT
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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