Eu Ivdd
Eu Ivd General
No Longer On The Market
🇨🇳 China
Sharay AMA-M2 IgG (CLIA)
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06975070760946
- Basic UDI-DI Code
- B-06975070760946
- Reference
- 18111001
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- No Longer On The Market
- Manufacturer
- C-Luminary Biotechnology Co., Ltd.
Additional Description
Sharay AMA-M2 IgG (CLIA) is intended for the In Vitro quantitative measurement of IgG antibody directed to AMA-M2 in human serum/plasma as an aid in the diagnosis of autoimmune liver diseases (ALD) in conjunction with other laboratory and clinical findings.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102100702 | ANTI-MITOCHONDRIAL ANTIBODIES |
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