cobasID CT NG Test Section 5: 510(k) Summary 510(k) Summary Report Roche Molecular Systems, Inc. Pleasanton, CA[removed] - Cobas - Document - PDFSEARCH.IO

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	cobasID CT/NG Test Section 5: 510(k) Summary 510(k) Summary Report Roche Molecular Systems, Inc. Pleasanton, CA[removed] Add to Reading List Document Date: 2014-01-14 08:01:16 Open Document File Size: 1,51 MB Share Result on Facebook City Pleasanton / / Company Summary Report Roche Molecular Systems Inc. / Summary Report Page 7 Roche Molecular Systems Inc. / Ilologic Inc. / Summary Report Page 2 Roche Molecular Systems Inc. / NC Analyte Targets INC / Summary Report PageS5 Roche Molecular Systems Inc. / Roche Molecular Systems Inc. / / Currency pence / / Event FDA Phase / / / IndustryTerm systemn software update / identified predicate device / fluorescence resonance energy transfer / system software / predicate device / / Organization I106 Unit / / / Position genomic DNA Sample Preparation Procedure Semi-automated Semi-automated Amplification Technology Real-time PCIR Real-time PCIR Detection Chemistry Paired reporter / PCR cycle threshold analysis Paired reporter / / Product K132270-510k / K1 / K132270 / I18 / K13227O-51Ok / / ProvinceOrState California / Connecticut / / Technology Perl / artificial intelligence / genomic DNA Sample Preparation Procedure Semi-automated Semi-automated Amplification Technology / / SocialTag Laboratory techniques Polymerase chain reaction Molecular biology Biotechnology Amplifiers Cobas Nucleic acid test Biology Chemistry Science

cobasID CT/NG Test Section 5: 510(k) Summary 510(k) Summary Report Roche Molecular Systems, Inc. Pleasanton, CA[removed]Add to Reading List