For in vitro diagnostic use. System cobas 8100 automated workflow series IVD cobas® 8100 automated workflow series SYS_249 07 091 109 001 7 091 109 001 07091109001 7091109001 07091109001 UCL Kit (CL8 + UCL + TSM) UCL Kit (CL8 + UCL + TSM) Instruments Not Available Not Available 10 165 367 001 10165367001 RFU for cobas 8100 RFU for cobas 8100 07613336228371 Accessories general (hardware) Not Available Not Available 07 050 763 001 7 050 763 001 07050763001 7050763001 07050763001 Automated Tip Loader (ATL) Automated Tip Loader (ATL) 04015630943722 Accessories general (hardware) Not Available Not Available 07 124 015 001 7 124 015 001 07124015001 7124015001 07124015001 cobas 8100 RFM (Reformatter - Version 1) cobas 8100 RFM (Reformatter - Version 1) 04015630943821 Instruments Not Available Not Available 10 165 391 001 10165391001 Single Tube Holder (Slim) Single Tube Holder (Slim) 07613336228395 Accessories general (hardware) Not Available Not Available Intended use for US only The cobas® 8100 automated workflow series is an automated, software-controlled system for processing patient samples before they go for analysis. The system is designed to centrifuge patient samples, remove and insert sample tube caps as required, apply barcode labels to secondary tubes, and prepare aliquots from primary samples. It can sort samples for online and offline analysis, and temporarily store samples. The system transports individual samples between modules, and to connected analyzers. The cobas® 8100 automated workflow series is intended for use with analyzers that perform tests in the areas of immunology, clinical chemistry, coagulation, urinalysis, and hematology. Supporting information for US only The cobas® 8100 automated workflow series is an in vitro diagnostic (IVD) medical equipment. Intended purpose for EU/EFTA and outside US The cobas® 8100 automated workflow series is an automated, software-controlled system for processing patient samples before they go for analysis. The system is designed to centrifuge patient samples, remove and insert sample tube caps as required, apply barcode labels to secondary tubes, and prepare aliquots from primary samples. It can sort samples for online and offline analysis, and temporarily store samples. The system transports individual samples between modules, and to connected analyzers. The cobas® 8100 automated workflow series is intended for use with analyzers that perform tests in the areas of immunology, clinical chemistry, coagulation, urinalysis, and hematology. Supporting information for EU/EFTA and outside US The cobas® 8100 automated workflow series is a fully automated system intended for sample workflow management. The cobas® 8100 automated workflow series is a fully automated and software controlled pre-analytical system for processing samples before and after online or offline analysis without assay testing function. The cobas® 8100 automated workflow series consists of pre-analytical modules (including sorting, centrifugation, tube decapping, secondary tube barcode labeling, aliquoting to secondary tube and recapping of tubes) and transport lines from pre-analytical modules to analyzers in order to realize the above intended purpose. The intended users of this device are trained laboratory technicians and trained field service engineers (professional use only). en

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