ANTI-DNA-MICROASSAY MULTIPLE DIAGNOSIS PRODUCTS MANUFACTURED BY GLOBALEMED, LLC

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ANTI-DNA-MICROASSAY MULTIPLE DIAGNOSIS PRODUCTS

Request for Information Form	Contact Information
Company Name	GLOBALEMED, LLC
Address	1101 KING STREET SUITES 370/270/170
City, State, Zip	ALEXANDRIA, VA 22314
Country	US
FDA Owner/Operator Phone	703-894-0710
FDA Medical Specialty Code	IM - Immunology
FDA Product Code	LRM
FDA Classification Name	ANTI-DNA ANTIBODY (ENZYME-LABELED), ANTIGEN, CONTROL
FDA Device Classification Code	Standards
FDA Regulation Number	866.5100
FDA Common Generic Name	ANTI-DNA-MICROASSAY MULTIPLE DIAGNOSIS PRODUCTS
FDA Proprietary Device Name	ANTI-DNA-MICROASSAY MULTIPLE DIAGNOSIS PRODUCTS
FDA Owner / Operator Number	9038669
FDA Owner / Operator Name	GLOBALEMED, LLC
FDA Establishment Registration Number	1064272
FDA Registered Establishment Name	GLOBALEMED, LLC
FDA Operation Code(s)	RR - Repackager/Relabeller
FDA Listing Date	09-20-00
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of GLOBALEMED, LLC

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	BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI 4000 ALFRED NOBEL DR. HERCULES, CA 94547 US 510-724-7000 / 510-741-6263	MULTIPLE	ENZYME IMMUNOASSAY ANTI-DNA ANTIBODY TEST
2	DIAMEDIX CORP. 2140 NORTH MIAMI AVE. MIAMI, FL 33127 US 305-324-2300 / 305-324-2354	IS-ANTIDS DNA ELISA TEST	DNA ELISA
3	GENBIO 15222 AVE. OF SCIENCE, SUITE A SAN DIEGO, CA 92128 US 858-592-9300 309 / 858-592-9300 309	IMMUNOWELL dsDNA ANTIBODY TEST KIT	ENZYME - LINKED IMMUNOASSAY - FOR dsDNA ANTIBODIES
4	HYCOR BIOMEDICAL LTD. PENTLANDS SCIENCE PARK BUSH LOAN EDINBURGH, EH26 OPL UK 44-131-445 7111 / 44-131-445 7111	AUTOSTAT II ANTI-DS DNA TEST KIT	AUTOSTAT II ANTI-DS DNA TEST KIT
5	IMMCO DIAGNOSTICS, INC. 60 PINEVIEW DR. BUFFALO, NY 14228 US 716-691-0091 / 716-691-0091	IMMCO DIAGNOSTICS IMMULISA ANTI-DSDNA ANTIBODY ASSAY	ANTI-DSDNA ANTIBODY ASSAY
6	MICRO DETECT, INC. 2852 WALNUT AVE., SUITE H-1 TUSTIN, CA 92780 US 714-832-8234 / 714-832-8234	MDI DS-DNA TEST	MDI DS-DNA TEST
7	MP BIOMEDICALS DIAGNOSTICS DIVISION 29525 FOUNTAIN PARKWAY SOLON, OH 44139 US 949-833-2500 / 440-337-1200 285	DSDNA ELISA	VARIOUS
8	ORGENTEC DIAGNOSTIKA GMBH CARL-ZEISS-STRASSE 49 MAINZ, 55129 GM 011-49-613192580 / 763-780-2955	ORGENTEC ANTI-DSDNA PIN IMMUNO ASSAY	ANTI-DSDNA ENZYME IMMUNIASSAY (EIA)
9	PHADIA GMBH MUNZINGER STRASSE 7 FREIBURG, D-79111 GM 46-18-165000 / 49-761-47805-278	MULTIPLE	ANTI DSDNA ANTIBODIES, ANTIGEN, CONTROLS
10	THE BINDING SITE BUILDING A WARSTOCK ROAD, KINGS HEATH BIRMINGHAM, B14 4RT UK 44-121-4361000 / 44-1-214361000	FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ELISA KIT	FARRZYME DSDNA ELISA KIT
11	TRINITY BIOTECH USA 2823 GIRTS RD. JAMESTOWN, NY 14701 US 353-127-69800 / 716-483-3851	MULTIPLE	DS DNA ELISA TEST SYSTEM
12	UNITED BIOTECH, INC. 211 S. WHISMAN ROAD, SUITE E MOUNTAIN VIEW, CA 94041 US 650-961-2910 / 650-961-2910	UBI MAGIWEL (TM) ANTI-DS-DNA QUANTITATIVE	ANTI-DS-DNA