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"ProductSpec": [
{
"ProductSpecVariant": {
"Chapters": [
{
"Name": "Intended Use",
"Value": "L'analyseur
cobas c 311 est un analyseur automatisé incluant un logiciel, destiné à effectuer des tests de chimie clinique qualitatifs, semi-quantitatifs et quantitatifs ainsi que des mesures sélectives d'ions.
Il s'agit d'un dispositif de DIV destiné à être utilisé en combinaison avec des tests de dépistage, de surveillance (aide à la surveillance), de diagnostic (aide au diagnostic) et de pronostic.
Les troubles spécifiques et les populations à tester sont couverts par les tests applicables exécutés sur l'instrument. Le type d'échantillon à utiliser comprend le sérum, l'urine, le liquide céphalorachidien, l'hémolysat, le sang total et le plasma qui sont utilisés pour détecter et/ou mesurer les analytes couverts par les tests spécifiques.
Les utilisateurs prévus de ce dispositif sont des techniciens de laboratoire formés et des ingénieurs de service sur le terrain formés (usage professionnel uniquement).",
"Language": "fr",
"Country": "XG",
"Code": "Intended Use"
},
{
"Name": "Specification",
"Value": "
| |
| Testing capabilities | Clinical chemistry, ISE, HbA1c (whole blood measurement) |
| Throughput | Up to 300 tests/hr for photometry tests only
450 tests/hr for only ISE tests |
| Samples | Serum, plasma, whole blood, urine, cerebrospinal fluid (CSF), supernatant (hemolysate)
Automated sample rerun and dilution
Additional sample loading during operation |
| Test integrity measures | Contact-free ultrasonic mixing
Determination of 3 serum indices (lipemic, hemolytic, icteric)
Sample clot detection |
| Reagents | Up to 45 reagent positions (42 cassette positions and 3 channels for ISE)
Barcoded cobas c reagent packs |
",
"Language": "en",
"Country": "XG",
"Code": "Specification"
}
]
}
}
]
}
