Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
Carbapenem Resistance Gene Detection Kit(Fluorescence PCR)
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- D-000012807194077RD
- Basic UDI-DI Code
- B-000012807194077RD
- Reference
- HWTS-OT045
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Additional Description
This kit is used for the qualitative detection of carbapenem resistance genes in human sputum samples, rectal swab samples or pure colonies, including KPC (Klebsiella pneumonia carbapenemase), NDM (New Delhi metallo-β-lactamase 1), OXA48 (oxacillinase 48), OXA23 (oxacillinase 23), VIM (Verona Imipenemase), and IMP (Imipenemase).The test results are used as a clinical aid in the diagnosis of patients with suspected carbapenem resistance.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0104080606 | NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE |
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