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"Value": "Intended use for US only
The cobas® 8000 modular analyzer series is a fully automated random-access software-controlled system for immunoassays and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests.
The cobas® 8000 modular analyzer series is an in vitro diagnostic (IVD) medical equipment.
Intended purpose for EU/EFTA and outside US
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.",
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