AFFYMETRIX GENECHIP MICROARRY INSTRUMENTATION SYSTEM MANUFACTURED BY AFFYMETRIX, INC.

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Request for Information Form	Contact Information
Company Name	AFFYMETRIX, INC.
Address	890 EMBARCADERO DR.
City, State, Zip	WEST SACRAMENTO, CA 95605
Country	US
FDA Owner/Operator Phone	408-731-5000
FDA Medical Specialty Code	CH - Clinical Chemistry
FDA Product Code	NSU
FDA Classification Name	INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS
FDA Device Classification Code	Standards
FDA Regulation Number	862.2570
FDA Common Generic Name	AFFYMETRIX SCANNER, AUTOLOADER, FLUIDICS STATION, GCOSDX SOFTWARE, AND WORKSTATI
FDA Proprietary Device Name	AFFYMETRIX GENECHIP MICROARRY INSTRUMENTATION SYSTEM
FDA Owner / Operator Number	9066102
FDA Owner / Operator Name	AFFYMETRIX, INC.
FDA Establishment Registration Number	3003314809
FDA Registered Establishment Name	AFFYMETRIX, INC.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	01-03-05
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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	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	AUTOGENOMICS, INCORPORATED 2251 RUTHERFORD ROAD CARLSBAD, CA 92008 US 760-804-7378 / 760-807-7378 345	INFINITI ANALYZER	INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS
2	BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI 4000 ALFRED NOBEL DR. HERCULES, CA 94547 US 510-724-7000 / 510-741-6263	BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM	MULTI-ANALYTE DETECTION SYSTEM