ANTI-SM, ANTI-RNP MULTIPLE DIAGNOSIS PRODUCTS MANUFACTURED BY GLOBALEMED, LLC

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ANTI-SM, ANTI-RNP 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	LKP
FDA Classification Name	ANTI-SM ANTIBODY, ANTIGEN AND CONTROL
FDA Device Classification Code	Standards
FDA Regulation Number	866.5100
FDA Common Generic Name	ANTI-SM, ANTI-RNP MULTIPLE DIAGNOSIS PRODUCTS
FDA Proprietary Device Name	ANTI-SM, ANTI-RNP 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	09-19-00
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	ENZYME IMMUNOASSAY ANTI-SM ANTIBODY TEST KIT	ENZYME IMMUNOASSAY ANTI-SM ANTIBODY TEST KIT
2	CORGENIX, INC. 11575 MAIN ST. SUITE 400 BROOMFIELD, CO 80020 US 303-457-4345 / 303-457-4345 130	MULTIPLE	SM ANTIBODIES
3	DIAGNOSTIC CHEMICALS LTD. 16 MCCARVILLE ST. CHARLOTTETOWN, P.E.I., C1E 2A6 CA 902-566-1396 / 902-566-1396	ACETAMINOPHEN ASSAYS	ACETAMINOPHEN ASSAYS
4	GENBIO 15222 AVE. OF SCIENCE, SUITE A SAN DIEGO, CA 92128 US 858-592-9300 309 / 858-592-9300 309	IMMUNOWELL SM ANTIBODY TEST KIT	ENZYME - LINKED IMMUNOASSAY - FOR SM ANTIBODIES
5	HYCOR BIOMEDICAL LTD. PENTLANDS SCIENCE PARK BUSH LOAN EDINBURGH, EH26 OPL UK 44-131-445 7111 / 44-131-445 7111	AUTOSTAT II ANTI-SM ELISA	AUTOSTAT II SM ELISA
6	IMMCO DIAGNOSTICS, INC. 60 PINEVIEW DR. BUFFALO, NY 14228 US 716-691-0091 / 716-691-0091	ANTI-SM POSITIVE CONTROL	ANTI-SM POSITIVE CONTROL
7	MARDX DIAGNOSTICS, INC. 5919 FARNSWORTH CT. CARLSBAD, CA 92008 US 353-127-69800 / 716-483-3851 1030	ANTI-SMOOTH MUSCLE IFA	SMA TEST SYSTEM/RAT STOMACH
8	MBL INTERNATIONAL CORP. 15 B CONSTITUTION WAY WOBURN, MA 01801 US 052-971-2081 / 781-939-6964	RHIGENE MESACUP-2 TEST - SM	SM ELISA KIT
9	MBL INTERNATIONAL CORPORATION 15B CONSTITUTION WAY WOBURN, MA 01801 US 052-971-2081 / 781-939-6964	MESACUP-2 TEST SM	ANTI-SM ELISA TEST
10	ORGENTEC DIAGNOSTIKA GMBH CARL-ZEISS-STRASSE 49 MAINZ, 55129 GM 011-49-613192580 / 763-780-2955	ORGENTEC ANTI-SM (SMITH) PIN IMMUNO ASSAY	ANTI-SM
11	PHADIA GMBH MUNZINGER STRASSE 7 FREIBURG, D-79111 GM 46-18-165000 / 49-761-47805-278	MULTIPLE	ANTI SM ANTIBODIES, ANTIGEN AND CONTROLS
12	QUEST INTL., INC. 1938 N.E. 148TH TERR. NORTH MIAMI, FL 33181 US 305-948-8788 / 305-948-8788	SERAQUEST ANTI-SM	ANTI-SM, SEROLOGICAL REAGENTS, ELISA