Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06956299702856
- Basic UDI-DI Code
- B-06956299702856
- Reference
- 801177
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Xiamen Zeesan Biotech Co., Ltd.
Additional Description
The MDR-TB Test Kit (Sanity 2.0) (Abbreviation: Sanity MDR-TB) is a cartridge-based test kit for detecting multidrug-resistance mutations (including rifampin-resistant mutations and isoniazid-resistant mutations) in Mycobacterium tuberculosis (MTB) from sputum samples.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105900102 | REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS |
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