FACTOR II (PROTHROMBIN) G20210A KIT MANUFACTURED BY ROCHE DIAGNOSTICS GMBH

Please Login or Create an Account Now.

This company has been viewed 358 times within the past 60 days.

This product has been viewed: 312 times.

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	HE - Hematology
FDA Product Code	NPR
FDA Classification Name	TEST, FACTOR II G20210A MUTATIONS, GENOMIC DNA PCR
FDA Device Classification Code	Standards
FDA Regulation Number	864.7280
FDA Common Generic Name	FACTOR II MUTATION ASSAY
FDA Proprietary Device Name	FACTOR II (PROTHROMBIN) G20210A KIT
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	01-15-04
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 companyies may manufacture a similar device.

	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 SYSTEM ASSAY FOR FACTOR II	TEST,FACTOR II G20210A MUTATIONS,GENOMIC DNA PCR