Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
Mycobacterium Tuberculosis Isoniazid Resistance Mutation Detection Kit(Melting Curve)
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- D-000012807171092PW
- Basic UDI-DI Code
- B-000012807171092PW
- Reference
- HWTS-RT137
- 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 in vitro qualitative detection of the main mutation sites in sputum samples collected from Tubercle bacillus positive patients that lead to mycobacterium tuberculosis isoniazid resistance: mutations at InhA promoter region -15C>T, -8T>A, -8T>C; AhpC promoter region -12C>T, -6G>A; KatG 315 codon 315G>A, 315G>C.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105010703 | MYCOBACTERIAL DETECTION BY NA REAGENTS |
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