Report Page 1 Roche Molecular Systems Inc. / ilologic Inc. / Report Page 7 Roche Molecular Systems Inc. / Report Page 2 Roche Molecular Systems Inc. / The Roche Molecular Systems / Roche Molecular Systems Inc. / Summary Report Roche Molecular Systems Inc. / Report PageS8 Roche Molecular Systems Inc. / Report Page 3 Roche Molecular Systems Inc. / Report Page 9 Roche Molecular Systems Inc. / Microsoft / Report Page 6 Roche Molecular Systems Inc. / MAY05 26 Roche Molecular Systems Inc. / /
Event
FDA Phase / / /
IndustryTerm
software system / internal instrument control software / clinical multiplex test systems / software guides / software wizard / diagnostic sample processing / instrument software / main software / software version / software processes / telecommunications / software tracks / raw fluorescence data using data analysis algorithms / software system version / real-time detection / identified predicate device / fundamental scientific technology / software architecture / system software / software system changes / marketed device / /
OperatingSystem
Microsoft Windows / /
Organization
NZ Control Unit / / /
Position
Integrated Work Order Editor / /
Product
510kSPFCIAL-510kSummary / CTNCGfri0kSPECIAL / /
ProgrammingLanguage
D / L / /
ProvinceOrState
California / Connecticut / /
Technology
raw fluorescence data using data analysis algorithms / firewall / fundamental scientific technology / hybridization / /
cobas®D CT/NO Test and cobas®D CT/NO Test, version[removed]k) Summary Report Roche Molecular Systems, Inc. Pleasanton, CA[removed]