RIA, IMMULITE, IML 1000, IML 2000, IML 2500 AFP MANUFACTURED BY SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITED

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Request for Information Form	Contact Information
Company Name	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITED
Address	GLYN RHONWY
City, State, Zip	LLANBERIS, CAERNARFON,
Country	UK
FDA Owner/Operator Phone	914-524-2955
FDA Medical Specialty Code	IM - Immunology
FDA Product Code	LOK
FDA Classification Name	KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
FDA Device Classification Code	Premarket Approval
FDA Regulation Number	NULL
FDA Common Generic Name	IMMUNOASSAY FOR THE MEASUREMENT OF AFP
FDA Proprietary Device Name	RIA, IMMULITE, IML 1000, IML 2000, IML 2500 AFP
FDA Owner / Operator Number	9096044
FDA Owner / Operator Name	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
FDA Establishment Registration Number	3002806944
FDA Registered Establishment Name	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITED
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	12-04-06
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	MULTIPLE	ALPHA-FETOPROTEIN
2	ABBOTT LABORATORIES 100 AND 200 ABBOTT PARK RD. ABBOTT PARK, IL 60064 US 847-937-6100 / 847-938-3471	MULTIPLE	ALPHA-FETOPROTEIN
3	BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. CHASKA, MN 55318 US 714-871-4848 / 714-993-5321 8383	ACCESS AFP REAGENTS	AFP ENZYME IMMUNOASSAY (EIA)
4	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5700 WEST 96TH ST. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955	RIA, IMMULITE, IML 1000, IML 2000, IML 2500 AFP	IMMUNOASSAY FOR THE MEASUREMENT OF AFP
5	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 333 CONEY ST. WALPOLE, MA 02032 US 914-524-2955 / 508-660-8540	ACS: 180 AFP	ALPH-FETOPROTEIN
6	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5210 PACIFIC CONCOURSE DR. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955	RIA, IMMULITE, IML 1000, IML 2000, IML 2500 AFP	IMMUNOASSAY FOR THE MEASUREMENT OF AFP
7	WAKO CHEMICALS USA, INC. 1600 BELLWOOD ROAD RICHMOND, VA 23237 US 816-620-33741 / 650-210-9153 109	AFP L3 DIFFERENTIATION TEST KIT	ALPHA FETOPROTEIN L3 DETERMINATION TEST KIT
8	WALLAC OY MUSTIONKATU 6 TURKU, 20750 FI 781-663-6900 / 358-226-78111	AUTODELFIA HAFP KIT	HAFP TIME-RESOLVED FLUOROIMMUNOASSAY