Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
🇹🇼 Taiwan
TBG ExProbe™ HLA ABCDRDQ Typing Kit, 10 tests/kit
Devices (same UDI-DI)
1
Certificates
1
Countries
3
Notified Bodies
1
Basic Information
- Primary DI
- D-47180503600661108365
- Basic UDI-DI Code
- B-47180503600661108365
- Reference
- 66110
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- On The Market
- Manufacturer
- TBG Biotechnology Corp.
Additional Description
This kit provides the HLA-ABCDRDQ typing results by performing real-time PCR method. This reagent is suitable for the sample, including the whole blood or white blood cells and other nuclear cells containing samples extracted from the nucleic acid samples.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0106010401 | HLA-TYPING |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | HL 2057895-1 | TÜV Rheinland LGA Products GmbH | Expired |
Available In Countries
🇬🇷 Greece
🇮🇹 Italy
🇵🇹 Portugal
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