IMMUCHEM PHE-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	JNB
FDA Classification Name	NINHYDRIN AND L-LEUCYL-L-ALANINE (FLUORIMETRIC), PHENYLALANINE
FDA Device Classification Code	Standards
FDA Regulation Number	862.1555
FDA Common Generic Name	PHENYLALANINE ASSAY
FDA Proprietary Device Name	IMMUCHEM PHE-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

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1	ASTORIA-PACIFIC,INC. 15130 S.E. 82ND DR. CLACKAMAS, OR 97015 US 503-657-3010 / 503-657-3010	SPOTCHECK-PHENYLALANINE KIT	FOR MEASURING PHENYLALANINE 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	QUANTASE, PHENYLALANINE ASSAY	QUANTASE, PHENYLALANINE ASSAY
3	METGEN,INCORPORATED 750 GLENRIDGE CLOSE DR. ATLANTA, GA 30328 US 404-256-1464 / 404-256-1464	PHENTEST BLOOD MONITOR-CHEMISTRY STRIP SYSTEM	PHENYLALANINE TEST SYSTEM
4	NEO-GENESIS, A DIVISION OF NATUS 15410 SE 82ND DR. SUITE 270 CLACKAMAS, OR 97015 US 503-657-8000 / 503-657-8000	ACCUWELL PHENYLALANINE	PHENYLALANINE TEST SYSTEM
5	WALLAC OY MUSTIONKATU 6 TURKU, 20750 FI 781-663-6900 / 358-226-78111	NEONATAL CHEMISTRY SYSTEM (NCS) PHENYLALANINE	NEONATAL PKU TEST
6	WATERS TECHNOLOGIES CORPORATION FLOATS RD. WYTHEYSHAWE, MANCHESTER, M39 9LZ UK 508-478-2000 / 508-482-2545	NEOLYMX SCREENING APPLICATION MANAGER	SCREENING SOFTWARE