Devices (same UDI-DI)
1
Certificates
2
Countries
12
Notified Bodies
2
Basic Information
- Primary DI
- 05060242472206
- Basic UDI-DI Code
- B-05060242472206
- Reference
- Z401
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List A
- Status
- On The Market
- Manufacturer
- Alba Bioscience Limited
Additional Description
These reagent red cells are presented as a 2-3% suspension of pooled washed red cells in Modified Alsever’s Solution. The Rh phenotype of the A1 red cells is ccdee.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0103030101 | ABO GROUPING CELLS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | 1434-IVDD-210/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | Expired |
| IVDD Annex IV Section 4 | 1434-IVDD-209/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | Expired |
Available In Countries
🇦🇹 Austria
🇨🇿 Czechia
🇩🇪 Germany
🇬🇷 Greece
🇫🇷 France
🇮🇪 Ireland
🇮🇹 Italy
🇱🇺 Luxembourg
🇳🇱 Netherlands
🇸🇪 Sweden
🇸🇰 Slovakia
🇬🇧 United Kingdom
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