Mycobacterium tuberculosis / Rifampin-resistance Mutation Detection Kit (PCR-Fluorescence Melting curve)
by Guangzhou Deaou Gene Technology Co., Ltd EUDAMED
Active
Model 8 tests/kit, 4 tests/kit
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-06976055490148 | Date25 Jan 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDD Expiring
Specification
- Device Name
- Mycobacterium tuberculosis / Rifampin-resistance Mutation Detection Kit (PCR-Fluorescence Melting curve)
- Model / Reference
- 8 tests/kit, 4 tests/kit
- Primary DI / UDI-DI
- 06976055490148, 06976055490155
- Basic UDI-DI
- B-06976055490148, B-06976055490155
- EMDN Code
- W0105010703 Mycobacterial detection by na reagents
- Device Class
- Class IVD General
- Market of Registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000033028
- Authorised representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
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Properties
Show properties
Other properties (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No