TINA-QUANT CRP (LATEX) HIGH SENSITIVITY MANUFACTURED BY ROCHE DIAGNOSTICS GMBH

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Request for Information Form	Contact Information
Company Name	ROCHE DIAGNOSTICS GMBH
Address	NONNENWALD 2
City, State, Zip	PENZBERG,
Country	GM
FDA Owner/Operator Phone	49-621-7670
FDA Medical Specialty Code	IM - Immunology
FDA Product Code	NQD
FDA Classification Name	CARDIAC C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL
FDA Device Classification Code	Standards
FDA Regulation Number	866.5270
FDA Common Generic Name	C-REACTIVE PROTEIN, HIGH SENSITIVITY
FDA Proprietary Device Name	TINA-QUANT CRP (LATEX) HIGH SENSITIVITY
FDA Owner / Operator Number	9036646
FDA Owner / Operator Name	ROCHE DIAGNOSTICS GMBH MANNHEIM
FDA Establishment Registration Number	9610529
FDA Registered Establishment Name	ROCHE DIAGNOSTICS GMBH
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	01-07-05
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	DADE BEHRING MARBURG GMBH 76 EMIL-VON-BEHRING STRASSE MARBURG, 35041 GM 847-267-5300 / 302-631-6311	CARDIOPHASE HSCRP	HSCRP- HIGH SENSITIVITY CRP
2	DADE BEHRING, INC. 500 GBC DR, MAILSTOP 514 NEWARK, DE 19714 US 847-267-5300 / 302-631-6311	MULTIPLE	VARIOUS HIGH SENSITIVITY CRP METHODS
3	OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA) LISMEEHAN O'CALLAGHANS MILLS, CO. CLARE, EI 040-237-73469 / 484-896-5688	CRP LATEX REAGENT	CRP LATEX REAGENT
4	ORTHO-CLINICAL DIAGNOSTICS, INC. 601 LEE RD. ROCHESTER, NY 14652 US 585-453-4469 / 585-453-3768	VITROS CHEMISTRY PRODUCTS HSCRP REAGENT	C-REACTIVE PROTEIN ASSAY
5	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5700 WEST 96TH ST. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955	IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN	HIGH SENSITIVITY C-REACTIVE PROTEIN IMMUNOASSAY
6	SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5210 PACIFIC CONCOURSE DR. LOS ANGELES, CA 90045 US 914-524-2955 / 914-524-2955	IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN	HIGH SENSITIVITY C-REACTIVE PROTEIN IMMUNOASSAY