Eu Ivdd
Eu Ivd General
On The Market
🇨🇦 Canada
THYROGLOBULIN AUTOANTIBODY
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- ++B261CANATG4150TY
- Basic UDI-DI Code
- B-++B261CANATG4150TY
- Reference
- CAN-ATG-4150
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Diagnostics Biochem Canada Inc.
Additional Description
For the quantitative measurement of Anti-Thyroglobulin (Anti-Tg) autoantibodies in human serum by an ELISA (Enzyme-Linked Immunosorbent Assay). Results shall be used in combination with other clinical and laboratory data to aid in the diagnosis of autoimmune thyroid diseases in the general population. This kit is intended for professional use only and is for laboratory use only. For in vitro diagnostic use only. Intended to be used manually but may be adaptable to open automated analyzers. The user is responsible for validating the performance of this kit with any automated analyzers.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102100303 | THYROGLOBULIN AUTOANTIBODY |
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