INNOFLUOR AMIKACIN ASSAY SY 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	TX - Clinical Toxicology
FDA Product Code	KLQ
FDA Classification Name	RADIOIMMUNOASSAY, AMIKACIN
FDA Device Classification Code	Standards
FDA Regulation Number	862.3035
FDA Common Generic Name	INNOFLUOR AMIKACIN ASSAY SY MULTIPLE DIAGNOSIS PRODUCTS
FDA Proprietary Device Name	INNOFLUOR AMIKACIN ASSAY SY 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	ABBOTT DIAGNOSTICS INTERNATIONAL, LTD. KM 58.0, CARRETERA 2 CRUCE DAVILA BARCELONETA, PR 00617 US 847-937-6100 / 847-938-3471	TDX/TDXFLX AMIKACIN	AMIKACIN
2	ABBOTT LABORATORIES 100 AND 200 ABBOTT PARK RD. ABBOTT PARK, IL 60064 US 847-937-6100 / 847-938-3471	TDX/TDXFLX AMIKACIN	AMIKACIN
3	DADE BEHRING, INC. 20400 MARIANI AVE. CUPERTINO, CA 95014 US 847-267-5300 / 302-631-6311	MULTIPLE	VARIOUS AMIKACIN TESTS
4	MEDICAL CHEMICAL CORP. 19430 VAN NESS AVE TORRANCE, CA 90501 US 310-787-6800 / 310-787-6800 235	CHLORAZOL BLACK E STAIN	CHLORAZOL BLACK E STAIN
5	RANDOX LABORATORIES LIMITED 44 LARGY ROAD CRUMLIN, CO.ANTRIM, BT29 4BN UK 44-28-90 422413 / 44-28-90422413	RANDOX AMIKACIN	AMIKACIN
6	RANDOX LABORATORIES LIMITED 36 LARGY ROAD CRUMLIN, CO.ANTRIM, BT29 4RW UK 44-28-90 422413 / 44-28-90422413	RANDOX AMIKACIN	AMIKACIN
7	SERADYN INC. 7998 GEORGETOWN RD. INDIANAPOLIS, IN 46268 US 412-490-8425 / 412-490-8425	INNOFLUOR AMIKACIN REAGENT SET	AMIKACIN REAGENT SET