Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
GENETIC TESTS - OTHER
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06930317801974
- Basic UDI-DI Code
- B-06930317801974
- Reference
- DNK-1901-20
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Dynamiker Biotechnology (Tianjin) Co., Ltd.
Additional Description
The MycoMDx Carbapenem resistance gene Assay (F-PCR) is used to qualitatively detect the specific nucleic acid fragments of 5 carbapenemase genes (KPC, NDM, VIM, IMP and OXA) of carbapenem resistant Enterobacteriaceae (CRE) in sputum or bacterial culture in vitro. It is mainly used for the auxiliary diagnosis of CRE infection.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W010699 | GENETIC TESTS - OTHER |
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