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For in vitro diagnostic use. System cobas 8000 modular analyzer series IVD cobas® 8000 modular analyzer series SYS_128 05 641 446 001 5 641 446 001 05641446001 5641446001 05641446001 cobas 8000 Core Unit cobas® 8000 core unit 07613336226605 Instruments Not Available Not Available 08 459 606 001 8 459 606 001 08459606001 8459606001 08459606001 cobas 8000 e 801 MSB/MSBL cobas 8000 modular analyzer series 07613336226643 Instruments Not Available Not Available 09 278 729 001 9 278 729 001 09278729001 9278729001 09278729001 cobas 8000 data manager G9 server cobas® 8000 Data Manager Instruments Not Available Not Available 05 990 378 001 5 990 378 001 05990378001 5990378001 05990378001 cobas 8000 - cobas e 602 module cobas e 602 module 04015630929764 Instruments Not Available Not Available 05 641 489 001 5 641 489 001 05641489001 5641489001 05641489001 cobas 8000 cobas c 701 module cobas c 701 module 07613336226612 Instruments Not Available Not Available 06 473 245 001 6 473 245 001 06473245001 6473245001 06473245001 cobas 8000 c702 module cobas c 702 module 07613336226629 Instruments Not Available Not Available 07 682 913 001 7 682 913 001 07682913001 7682913001 07682913001 cobas e 801 module cobas e 801 analytical unit 04015630946198 Instruments Not Available Not Available 08 680 523 001 8 680 523 001 08680523001 8680523001 08680523001 c8000 data manager server G9 cobas® 8000 Data Manager 07613336160886 Instruments Not Available Not Available 05 964 075 001 5 964 075 001 05964075001 5964075001 05964075001 cobas 8000 cobas ISE module (double) cobas® 8000 ISE module 07613336226667 Instruments Not Available Not Available 05 964 067 001 5 964 067 001 05964067001 5964067001 05964067001 cobas 8000 cobas c 502 module cobas c 502 module 04015630928354 Instruments Not Available Not Available 08 454 345 001 8 454 345 001 08454345001 8454345001 08454345001 cobas e 801 analytical unit cobas e 801 analytical unit 07613336226636 Instruments Not Available Not Available 05 641 497 001 5 641 497 001 05641497001 5641497001 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
