ALPHA-2 MACROGLOBULIN TEST MULTIPLE DIAGNOSIS PRODUCTS MANUFACTURED BY GLOBALEMED, LLC

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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	DEB
FDA Classification Name	ALPHA-2-MACROGLOBULIN, ANTIGEN, ANTISERUM, CONTROL
FDA Device Classification Code	Standards
FDA Regulation Number	866.5620
FDA Common Generic Name	ALPHA-2 MACROGLOBULIN TEST MULTIPLE DIAGNOSIS PRODUCTS
FDA Proprietary Device Name	ALPHA-2 MACROGLOBULIN TEST 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

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	BECKMAN COULTER, INC. 2470 FARADAY AVE. CARLSBAD, CA 92008 US 714-871-4848 / 714-993-5321 8383	MULTIPLE	ALPHA-2-MACROGLOBULIN
2	BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. CHASKA, MN 55318 US 714-871-4848 / 714-993-5321 8383	GOAT ANTISERA TO HUMAN ALPHA-2-MACROGLOBULIN	GOAT ANTISERA TO HUMAN ALPHA-2-MACROGLOBULIN
3	BECKMAN COULTER, INC. (IRELAND) MERVUE BUSINESS PARK GALWAY, EI 714-871-4848 / 714-993-8383	MULTIPLE	ALPHA-2-MACROGLOBULIN
4	DADE BEHRING MARBURG GMBH 76 EMIL-VON-BEHRING STRASSE MARBURG, 35041 GM 847-267-5300 / 302-631-6311	ANTISERUM TO HUMAN ALPHA-2-MACROGLOBULIN	ANTISERUM TO HUMAN MACROGLOBULIN
5	DIAGNOSTICA-STAGO 2 RUE PIERRE FOSSATI FRANCONVILLE, 95130 FR 33-146-88 20 20 / 331-46-854851	NO PROPRIETARY NAME LISTED	NO COMMON NAME LISTED
6	DIASORIN, INC. 1951 NORTHWESTERN AVE. P.O. BOX 285 STILLWATER, MN 55082 US 390-161-487 093 / 651-351-5820	ANTI-HUMAN ALPHA-2-MACROGLOBULIN SERUM	ANTI-HUMAN ALPHA-2-MACROGLOBULIN ANTISERUM -NEPHELOMETRIC
7	KENT LABORATORIES, INC. 777 JORGENSEN PLACE BELLINGHAM, WA 98226 US 360-398-8641 / 360-398-8641	ALPHA-2-MACROGLOBULIN RADIAL IMMUNODIFFUSION KIT	ALPHA-2-MACROGLOBULIN IMMUNOLOGICAL TEST SYSTEM
8	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 BENEDICT AVENUE TARRYTOWN, NY 10591 US 914-524-2955 / 914-524-2955	MULTIPLE	MULTIPLE
9	THE BINDING SITE, INC. 5889 OBERLIN DR., SUITE 101 SAN DIEGO, CA 92121 US 858-453-9177 / 858-453-9177		IMMUNOLOGICAL TEST SYSTEM