Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
TB MPT64
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 16972698600200
- Basic UDI-DI Code
- B-16972698600200
- Reference
- P211010
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
Additional Description
It is an immunochromatographic assay (ICA) using anti-MPT64 monoclonal antibodies for directly qualitative detection of Mycobacterium tuberculosis complex (MTBC) antigen.（20 tests/kit，TB MPT64 PIus,Test Device with Extraction Tube ）
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105099099 | VIROLOGY - RT & POC - OTHER |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).
BluBox
Device
EU IVDD
·
Eu Ivd General
·Blusense Diagnostics ApS·On the market·5 countries
extendSURE™ HbA1c Liquid Controls
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·19 countries
ViroTrack Sero COVID-19 Total Ab
Device
EU IVDD
·
Eu Ivd General
·Blusense Diagnostics ApS·On the market·5 countries
extendSURETM Haemoglobin F and A2 Calibrators
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·8 countries
extendSURE™ Haemoglobin F and A2 Controls
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·8 countries
extendSURE™ HbA1c Liquid Controls
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·19 countries