For in vitro diagnostic use. System cobas 8000 modular analyzer series IVD cobas® 8000 modular analyzer series SYS_128 05641446001 cobas 8000 Core Unit cobas® 8000 core unit 07613336226605 Instruments Not Available Not Available 08459606001 cobas 8000 e 801 MSB/MSBL cobas 8000 modular analyzer series 07613336226643 Instruments Not Available Not Available 09278729001 cobas 8000 data manager G9 server cobas® 8000 Data Manager Instruments Not Available Not Available 05990378001 cobas 8000 - cobas e 602 module cobas e 602 module 04015630929764 Instruments Not Available Not Available 06473245001 cobas 8000 c702 module cobas c 702 module 07613336226629 Instruments Not Available Not Available 08680523001 c8000 data manager server G9 cobas® 8000 Data Manager 07613336160886 Instruments Not Available Not Available 05964075001 cobas 8000 cobas ISE module (double) cobas® 8000 ISE module 07613336226667 Instruments Not Available Not Available 05964067001 cobas 8000 cobas c 502 module cobas c 502 module 04015630928354 Instruments Not Available Not Available 08454345001 cobas e 801 analytical unit cobas e 801 analytical unit 07613336226636 Instruments Not Available Not Available 05641497001 cobas 8000 cobas ISE module cobas® 8000 ISE module 07613336226650 Instruments Not Available Not Available The cobas® 8000 modular analyzer series is an automated analyzer, intended for running qualitative, semi-quantitative and quantitative clinical chemistry and immunochemistry assays as well as ion-selective measurements.It is an IVD device intended to be used in combination with assays for screening, monitoring (aid in monitoring), diagnosis (aid to diagnosis) and prognosis; additionally, the device can be used to run companion diagnostic tests.The specific disorder and testing populations are covered by the applicable assays running on the instrument. The type of specimen to be used includes serum, plasma, urine, whole blood, cerebrospinal fluid, supernatant, oral fluid, hemolysate, amniotic fluid and processed stool, that are used for detecting and/or measuring analytes covered by the specific assays. The intended users of this device are trained laboratory technicians and trained field service engineers (professional use only). Inside EU/EFTA only, the cobas 8000 e 801 is also intended for use in blood donor screening in hospital blood banks, blood bank labs, and for blood donation testing at plasma fractionators. en