BAYER HER-2/NEU ASSAY ANALYTE SPECIFIC REAGENT (ASR) 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	PA - Pathology
FDA Product Code	MHQ
FDA Classification Name	PANEL, TUMOR, UNDIFFERENTIATED
FDA Device Classification Code	Premarket Approval
FDA Regulation Number	NULL
FDA Common Generic Name	ASR HER 2/NEU P105 ANTIGEN SOLUTION
FDA Proprietary Device Name	BAYER HER-2/NEU ASSAY ANALYTE SPECIFIC REAGENT (ASR)
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	12-14-99
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A