Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
ANDiS MTB RIF/INH Resistance Detection Kit
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06973685471103
- Basic UDI-DI Code
- B-06973685471103
- Reference
- 3000000000306
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- 3D Biomedicine Science & Technology Co., Limited
Additional Description
The ANDiS MTB RIF/INH Resistance Detection Kit is a polymerase chain reaction (PCR) assay for the qualitative detection of rifampicin (RIF)-resistance associated mutations of the rpoB gene, and isoniazid (INH) -resistance associated mutations in the katG and inhA genes of Mycobacterium tuberculosis (MTB) complex in sputum specimens that tested positive for MTB.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105010703 | MYCOBACTERIAL DETECTION BY NA REAGENTS |
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