BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM MANUFACTURED BY BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI

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Request for Information Form	Contact Information
Company Name	BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI
Address	4000 ALFRED NOBEL DR.
City, State, Zip	HERCULES, CA 94547
Country	US
FDA Owner/Operator Phone	510-724-7000
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	MULTI-ANALYTE DETECTION SYSTEM
FDA Proprietary Device Name	BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
FDA Owner / Operator Number	9929003
FDA Owner / Operator Name	BIO-RAD LABORATORIES, INC.
FDA Establishment Registration Number	2915274
FDA Registered Establishment Name	BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	11-07-05
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	AFFYMETRIX, INC. 890 EMBARCADERO DR. WEST SACRAMENTO, CA 95605 US 408-731-5000 / 617-359-6710	AFFYMETRIX GENECHIP MICROARRY INSTRUMENTATION SYSTEM	AFFYMETRIX SCANNER, AUTOLOADER, FLUIDICS STATION, GCOSDX SOFTWARE, AND WORKSTATI
2	AUTOGENOMICS, INCORPORATED 2251 RUTHERFORD ROAD CARLSBAD, CA 92008 US 760-804-7378 / 760-807-7378 345	INFINITI ANALYZER	INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS