Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
🇸🇬 Singapore
Sentosa SA CMV Quantitation Controls (4x2)
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 08885013953312
- Basic UDI-DI Code
- B-08885013953312
- Reference
- 300059
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- On The Market
- Manufacturer
- Vela Operations Singapore Pte. Ltd.
Additional Description
Sentosa SA CMV Quantitation Controls (4x2) provides control tubes (HPC and LPC) which function as additional positive controls with lot-specific concentration. The validity of these controls further assures the accuracy of CMV quantitation in a PCR-based test.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105040205 | CMV - NA REAGENTS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | HL 20744998-1 | TÜV Rheinland LGA Products GmbH | Expired |
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