Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
TSH Rapid Test Device (serum/plasma/whole blood)
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06976753475294
- Basic UDI-DI Code
- B-06976753475294
- Reference
- C120501D
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Hangzhou Cybereagen Biotech Co., Ltd.
Additional Description
"TSH Rapid Test Device (serum/plasma/whole blood) is a rapid chromatographic immunoassay for the qualitative detection of Thyroid Stimulating Hormone (TSH) in whole blood, serum, or plasma to aid in the screening the adult population for primary hypothyroidism by medical professionals. It is not indicated for use in screening neonates for hypothyroidism."
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01020410 | THYROID STIMULATING HORMONE |
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