Eu Ivdr
Eu Ivd Class C
On The Market
π¨π³ China
EasyNAT MTC Assay
Devices (same UDI-DI)
1
Certificates
0
Countries
2
Notified Bodies
0
Basic Information
- Primary DI
- 06973492240138
- Basic UDI-DI Code
- 697349224U2010032C000DP
- Reference
- U20103
- Device Types
-
Single use
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class C
- Status
- On The Market
- Manufacturer
- Ustar Biotechnologies (Hangzhou) Ltd.
Additional Description
This kit is an automated, in vitro nucleic acid amplification test intended for the qualitative detection of Mycobacterium Tuberculosis Complex (MTC) DNA in human sputum sample from asymptomatic and symptomatic individuals. It is used as an auxiliary test for the diagnosis of pulmonary tuberculosis (TB) when used in conjunction with clinical and other laboratory observations.This kit is not for near patient and self-testing.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105010703 | MYCOBACTERIAL DETECTION BY NA REAGENTS |
Available In Countries
π«π· France
π³π± Netherlands
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