GLOBALEMED SMART CHECK CHAGAS DEVICE/STRIP MANUFACTURED BY GLOBALEMED SA (PTY) LTD.

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Request for Information Form	Contact Information
Company Name	GLOBALEMED SA (PTY) LTD.
Address	MONTAGUE DRIVE MONTAGUE GARDENS, CAPE TOWN
City, State, Zip	WESTERN PROVINCE,
Country	SF
FDA Owner/Operator Phone	703-894-0710
FDA Medical Specialty Code	MI - Microbiology
FDA Product Code	MIU
FDA Classification Name	ENZYME LINKED IMMUNOSORBENT ASSAY, T. CRUZI
FDA Device Classification Code	General Controls
FDA Regulation Number	866.3870
FDA Common Generic Name	CHAGAS RAPID TEST
FDA Proprietary Device Name	GLOBALEMED SMART CHECK CHAGAS DEVICE/STRIP
FDA Owner / Operator Number	9038669
FDA Owner / Operator Name	GLOBALEMED, LLC
FDA Establishment Registration Number	3005030887
FDA Registered Establishment Name	GLOBALEMED SA (PTY) LTD.
FDA Operation Code(s)	RR - Repackager/Relabeller
FDA Listing Date	02-15-05
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	CHEMBIO DIAGNOSTIC SYSTEMS, INC. 3661 HORSEBLOCK RD. MEDFORD, NY 11763 US 631-924-1135 / 631-924-1135	CHAGAS STAT-PAK	IMMUNOCHROMATOGRAPHIC ASSAY FOR VISUAL DETECTION OF ANTIBODIES TO T.CRUZI
2	GLOBALEMED, LLC 1101 KING STREET SUITES 370/270/170 ALEXANDRIA, VA 22314 US 703-894-0710 / 703-894-0710 218	CHAGA'S IGG ELISA TEST MULTIPLE DIAGNOSIS PRODUCTS	CHAGA'S IGG ELISA TEST MULTIPLE DIAGNOSIS PRODUCTS
3	MERIDIAN BIOSCIENCE, INC. 3471 RIVER HILLS DR. CINCINNATI, OH 45244 US 513-271-3700 / 513-271-3700 229	PREMIER CHARGES IGG	PREMIER CHARGES IGG
4	WIENER LABORATORIOS S.A.I.C. 2571 MAIPU ROSARIO SANTA FE, 2000 AR 011-543-414851982 / 011-543-414851982	CHAGATEST ELISA RECOMBINANTE V.3.0	EMZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DETECTION OF ANTIBODIES TO TRY