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| EMDDB code |
22241
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| Basic UDI-DI |
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| Seadme klass |
In vitro diagnostikameditsiiniseade
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| Medical Device Nomenclature |
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| Risk class |
General IVD 98/79/EC
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| Appliance |
-
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| Device name (in Estonian) |
BD MAX™ MDR-TB
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| Device name (in English) |
BD MAX™ MDR-TB
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| Intended use (is Estonian) |
Süsteemil BD MAX™ tehtud Multi Drug Resistant Tuberculosis (MDR-TB) (Multiresistentse tuberkuloosi analüüs) on automatiseeritud kvalitatiivne in vitro diagnostiline test Mycobacterium tuberculosis kompleksi (MTBC) DNA otsetuvastamiseks toorsülje- või kontsentreeritud süljesettest indutseeritud või ekspektoreeritud süljeproovist. Proovidest, milles tuvastatakse
MTBC DNA-d, tuvastab analüüs BD MAX™ MDR-TB ka rpoB geeni mutatsioone, mida seostatakse rifampiini-resistentsusega ning katG geeni ja inhA promootorpiirkonna mutatsioone, millest mõlemaid seostatakse isoniasiidi-resistentsusega.
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| Intended use (in English) |
The BD MAX™ Multi Drug Resistant Tuberculosis (MDR-TB) assay, performed on the BD MAX™ System, is an automated
qualitative in vitro diagnostic test for the direct detection of Mycobacterium tuberculosis complex (MTBC) DNA in raw sputum or concentrated sputum sediments prepared from induced or expectorated sputa. In specimens where MTBC DNA is detected, BD MAX™ MDR-TB also detects mutations in the rpoB gene associated with rifampin resistance as well as mutations in the katG gene and inhA promoter region both of which are associated with isoniazid resistance.
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| Type/model/article number |
443878
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| Manufacturer |
Becton, Dickinson and Company
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| Authorised representative |
Benex Limited
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| In register from |
06/16/2025
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| Entry status |
Active
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| Reimbursed by EHIF |
Tervisekassa soodustus puudub
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