| EMDDB code |
22242
|
| Basic UDI-DI |
|
| Seadme klass |
In vitro diagnostikameditsiiniseade
|
| Medical Device Nomenclature |
|
| Risk class |
General IVD 98/79/EC
|
| Appliance |
-
|
| Device name (in Estonian) |
Enteraalsete bakterite paneel BD MAX™
|
| Device name (in English) |
BD MAX™ Enteric Bacterial Panel
|
| Intended use (is Estonian) |
Süsteemis BD MAX™ System kasutatav BD MAX™ Enteric Bacterial Panel on automatiseeritud in vitro diagnostiline test patogeensete enteraalsete bakteriaalsete patogeenide otseseks kvalitatiivseks määramiseks ja eristamiseks. BD MAX™ Enteric Bacterial Panel tuvastab järgmiste bakterite nukleiinhappeid:
•Salmonella spp.
•Campylobacter spp. (jejuni ja coli)
•Shigella spp. / Enteroinvasiivne E. coli (EIEC)
•Shiga-toksiin 1 (stx1) / Shiga-toksiin 2 (stx2) geenid (leiduvad Shiga-toksiini tootvas E. coli's [STEC]) ning Shigella dysenteriae's, millel võib olla Shiga-toksiini geen (stx), mis on identne STEC-i stx1 geeniga.
|
| Intended use (in English) |
The BD MAX™ Enteric Bacterial Panel performed on the BD MAX™ System is an automated in vitro diagnostic test for the direct qualitative detection and differentiation of enteric bacterial pathogens. The BD MAX™ Enteric Bacterial Panel detects nucleic acids from:
•Salmonella spp.
•Campylobacter spp. (jejuni and coli)
•Shigella spp. / Enteroinvasive E. coli (EIEC)
•Shiga toxin 1 (stx1) / Shiga toxin 2 (stx2) genes (found in Shiga toxin-producing E. coli [STEC]) as well as Shigella dysenteriae, which can possess a Shiga toxin gene (stx) that is identical to the stx1 gene of STEC.
|
| Type/model/article number |
442963
|
| Manufacturer |
Becton, Dickinson and Company
|
| Authorised representative |
Benex Limited
|
| In register from |
06/16/2025
|
| Entry status |
Active
|
| Reimbursed by EHIF |
Tervisekassa soodustus puudub
|
