ACCUWELL TOTAL GALACTOSE 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	CH - Clinical Chemistry
FDA Product Code	JIA
FDA Classification Name	ENZYMATIC METHODS, GALACTOSE
FDA Device Classification Code	General Controls
FDA Regulation Number	862.1310
FDA Common Generic Name	ACCUWELL TOTAL GALACTOSE MULTIPLE DIAGNOSIS PRODUCTS
FDA Proprietary Device Name	ACCUWELL TOTAL GALACTOSE 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	ASTORIA-PACIFIC,INC. 15130 S.E. 82ND DR. CLACKAMAS, OR 97015 US 503-657-3010 / 503-657-3010	SPOTCHECK-GALACTOSE KIT	FOR DETERMINING GALACTOSE CONTENT IN INFANT BLOOD SERUM
2	BIO-RAD LABORATORIES EUROPE, LTD. 3 RIVERVIEW BUSINESS PARK FRIARTON ROAD PERTH, SCOTLAND, PH2 8DF UK 510-724-7000 / 510-741-6263	MULTIPLE	VARIOUS
3	MP BIOMEDICALS DIAGNOSTICS DIVISION 29525 FOUNTAIN PARKWAY SOLON, OH 44139 US 949-833-2500 / 440-337-1200 285	IMMUCHEM GAL-MW EA	GALACTOSE ENZYME ASSAY
4	NEO-GENESIS, A DIVISION OF NATUS 15410 SE 82ND DR. SUITE 270 CLACKAMAS, OR 97015 US 503-657-8000 / 503-657-8000	ACCUWELL TOTAL GALACTOSE	GALACTOSE TEST SYSTEM