ADVIA 1650 REAGENT SPECIFIC PROTEIN CALIBRATOR, LOW MANUFACTURED BY SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS

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Request for Information Form	Contact Information
Company Name	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
Address	511 BENEDICT AVENUE
City, State, Zip	TARRYTOWN, NY 10591
Country	US
FDA Owner/Operator Phone	914-524-2955
FDA Medical Specialty Code	IM - Immunology
FDA Product Code	DER
FDA Classification Name	ALPHA-1-LIPOPROTEIN, ANTIGEN, ANTISERUM, CONTROL
FDA Device Classification Code	Standards
FDA Regulation Number	866.5580
FDA Common Generic Name	ADVIA 1650 REAGENT
FDA Proprietary Device Name	ADVIA 1650 REAGENT SPECIFIC PROTEIN CALIBRATOR, LOW
FDA Owner / Operator Number	9096044
FDA Owner / Operator Name	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
FDA Establishment Registration Number	2432235
FDA Registered Establishment Name	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
FDA Operation Code(s)	MS - Specification Developer
FDA Listing Date	03-11-02
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	CAROLINA LIQUID CHEMISTRIES CORP. 510 W. CENTRAL AVE. SUITE C BREA, CA 92821 US 800-471-7272 / 800-471-7272	APO-A1, APO B	LIPOPROTEIN
2	DIASORIN, INC. 1951 NORTHWESTERN AVE. P.O. BOX 285 STILLWATER, MN 55082 US 390-161-487 093 / 651-351-5820	SPQ TEST SYSTEM FOR APOLIPOPROTEIN A-1	TURBIMETRIC ASSAY FOR APOLIPOPROTEIN A-1
3	KAMIYA BIOMEDICAL CO. 12779 GATEWAY DR. SEATTLE, WA 98168 US 206-575-8068 / 206-575-8068	MULTIPLE	VARIOUS
4	NITTO BOSEKI CO., LTD. (MEDICAL DIVISION) 4-1-28 KUDAN-KITA CHIYODA-KU TOKYO, 102-0073 JA 81-3-32384540 / 206-575-8068	MULTIPLE	VARIOUS IMMUNOTURBIDIMETRIC ASSAYS
5	REAGENTS APPLICATIONS, INC. 8225 MERCURY CT. SAN DIEGO, CA 92111 US 800-436-2436 / 443-367-5501	RAICHEM;SPIA;APO A-1 REAGENT	REAGENT FOR APOLIPOPROTEIN DETERMINATION, IMMUNOLOGICAL