HTLV 1/11 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	HE - Hematology
FDA Product Code	MTP
FDA Classification Name	ANTIBODY TO HTLV-1, ELISA
FDA Device Classification Code	Premarket Approval
FDA Regulation Number	NULL
FDA Common Generic Name	HTLV 1/11 MULTIPLE DIAGNOSIS PRODUCTS
FDA Proprietary Device Name	HTLV 1/11 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

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	ABBOTT LABORATORIES 100 AND 200 ABBOTT PARK RD. ABBOTT PARK, IL 60064 US 847-937-6100 / 847-938-3471	ABBOTT HTLV-I/HTLV-II EIA	IN-VITRO ENZYME IMMUNOASSAY FOR THE QUALITATIVE DETECTION OF ANTIBODIES TO HUMAN
2	BIOMERIEUX, INC. 100 RODOLPHE ST DURHAM, NC 27712 US 33-478-872063 / 314-731-8594	VIRONOSTIKA HTLV-1/II MICROELISA SYSTEM	VIRONOSTIKA HTLV-1/II MICROELISA SYSTEM