IMMUCHEM GAL-MW EA MANUFACTURED BY MP BIOMEDICALS DIAGNOSTICS DIVISION

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Request for Information Form	Contact Information
Company Name	MP BIOMEDICALS DIAGNOSTICS DIVISION
Address	29525 FOUNTAIN PARKWAY
City, State, Zip	SOLON, OH 44139
Country	US
FDA Owner/Operator Phone	949-833-2500
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	GALACTOSE ENZYME ASSAY
FDA Proprietary Device Name	IMMUCHEM GAL-MW EA
FDA Owner / Operator Number	9057708
FDA Owner / Operator Name	MP BIOMEDICALS, LLC
FDA Establishment Registration Number	2419955
FDA Registered Establishment Name	MP BIOMEDICALS DIAGNOSTICS DIVISION
FDA Operation Code(s)	MM - Manufacturer MR - Remanufacturer RR - Repackager/Relabeller
FDA Listing Date	07-11-96
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.

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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	GLOBALEMED, LLC 1101 KING STREET SUITES 370/270/170 ALEXANDRIA, VA 22314 US 703-894-0710 / 703-894-0710 218	ACCUWELL TOTAL GALACTOSE MULTIPLE DIAGNOSIS PRODUCTS	ACCUWELL TOTAL GALACTOSE MULTIPLE DIAGNOSIS PRODUCTS
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