Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
TSH Sneltest Cassette
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06936983167673
- Basic UDI-DI Code
- B-06936983167673
- Reference
- OTS-402H
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Hangzhou Alltest Biotech.Co.,Ltd.
Additional Description
De TSH Sneltest Cassette is een snelle chromatografische immunoassay voor de kwalitatieve detectie van TSH in menselijk volbloed bij een grensconcentratie van 5μIU/mL. Deze test biedt een voorlopig diagnostisch testresultaat en kan worden gebruikt voor screening op TSH.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102160903 | THYROID-STIMULATING HORMONE - RT & POC |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | VCQ0951230013 | TÜV SÜD Product Service GmbH | Expired |
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