Basic Information
- Primary DI
- 05060242470820
- Basic UDI-DI Code
- B-05060242470820
- Reference
- Z489
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List A
- Status
- On The Market
- Manufacturer
- Alba Bioscience Limited
Additional Description
ALBAcheck-BGS Simulated Whole Blood Controls have been prepared from red blood cells collected from blood donors. Each individual vial contains known ABO, Rh and K blood group antigens plus ABO and irregular blood group antibodies listed below. Red blood cells are of human origin. ABO and Anti-D antibodies are of monoclonal origin and Anti-K antibodies are of polyclonal origin. Vial 1- Group A, R1R1, K positive containing Anti-B. Vial 2- Group B, R1R2, K negative containing Anti-A and Anti-K. Vial 3- Group O, R2R2, K negative containing Anti-A and Anti-B. Vial 4 - Group AB, rr, K negative containing Anti-D. The concentration of red cells in each of the vials has been adjusted to 15±2%. The red cells are suspended in a preservative solution to retard haemolysis and bacterial contamination.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0103030402 | CONTROL KITS (IMMUNOHAEMATOLOGY) |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | 1434-IVDD-121/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | Expired |
| IVDD Annex IV Section 4 | 1434-IVDD-120/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Annex 2 List A) and regulation (EU IVDD).