NEONATAL CHEMISTRY SYSTEM (NCS) PHENYLALANINE MANUFACTURED BY WALLAC OY

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Request for Information Form	Contact Information
Company Name	WALLAC OY
Address	MUSTIONKATU 6
City, State, Zip	TURKU,
Country	FI
FDA Owner/Operator Phone	781-663-6900
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	NEONATAL PKU TEST
FDA Proprietary Device Name	NEONATAL CHEMISTRY SYSTEM (NCS) PHENYLALANINE
FDA Owner / Operator Number	9912035
FDA Owner / Operator Name	PERKINELMER, INC.
FDA Establishment Registration Number	8043909
FDA Registered Establishment Name	WALLAC OY
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	06-10-04
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
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4	MP BIOMEDICALS DIAGNOSTICS DIVISION 29525 FOUNTAIN PARKWAY SOLON, OH 44139 US 949-833-2500 / 440-337-1200 285	IMMUCHEM PHE-MW EA	PHENYLALANINE ASSAY
5	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
6	WATERS TECHNOLOGIES CORPORATION FLOATS RD. WYTHEYSHAWE, MANCHESTER, M39 9LZ UK 508-478-2000 / 508-482-2545	NEOLYMX SCREENING APPLICATION MANAGER	SCREENING SOFTWARE