Eu Ivdd
Eu Ivd Annex 2 List A
On The Market
🇵🇱 Poland
Zestaw Próbek Kontrolnych do codziennej kontroli odczynników diagnostycznych i krwinek wzorcowych do układu ABO i RhD ZPK I
Devices (same UDI-DI)
1
Certificates
2
Countries
0
Notified Bodies
2
Basic Information
- Primary DI
- 05904365620130
- Basic UDI-DI Code
- B-05904365620130
- Reference
- 931
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List A
- Status
- On The Market
Additional Description
Zestaw Próbek Kontrolnych stanowią dwie probówki typu „próbka pacjenta” zawierające po 5 ml zawiesiny krwinek czerwonych i z osocza (hematokryt 15% +/-2%): • Próbka Kontrolna 1 931-K1 - grupa A RhD- dccee K -, • Próbka Kontrolna 2 931-K2 - grupa B RhD+ DCcEe K+.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0103030402 | CONTROL KITS (IMMUNOHAEMATOLOGY) |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | 1434-IVDD-160/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | Expired |
| IVDD Annex IV Section 4 | 1434-IVDD-159/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | Expired |
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