Freeze-dried Mycobacterium Tuberculosis Nucleic Acid and Rifampicin, Isoniazid Resistance Detection Kit (Melting Curve)
Let the assistant research this device
The Research Assistant compiles risk class, certificates, notified bodies and related records — and cites every one.
Free to try · every answer cites its records
Basic Information
- Primary DI
- D-0000128071390DAS4
- Basic UDI-DI Code
- B-0000128071390DAS4
- Reference
- HWTS-RT105
- 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
The kit is used for the in vitro qualitative detection of the mutations in mycobacterium tuberculosis complex nucleic acid and sputum samples positive for mycobacterium tuberculosis complex from tuberculosis patients, which are in the 507-533 amino acid codon region (81bp, rifampicin resistance-determining region) of rifampicin-resistant rpoB gene, and in the main mutation sites of isoniazid resistance, such as InhA promoter region -15C>T, -8T>A, -8T>C; AhpC promoter region -12C>T, -6G>A; KatG 315 codon 315G>A, 315G>C; InhA 94 codon T>G. This product cannot determine the specific mutation type.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105010703 | MYCOBACTERIAL DETECTION BY NA REAGENTS |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).