Eu Ivdd
Eu Ivd Annex 2 List A
On The Market
🇹🇼 Taiwan
GB HIV Ag-Ab COMB
Devices (same UDI-DI)
1
Certificates
2
Countries
0
Notified Bodies
2
Basic Information
- Primary DI
- 04712803531327
- Basic UDI-DI Code
- B-04712803531327
- Reference
- 4EAIC13
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List A
- Status
- On The Market
- Manufacturer
- General Biologicals Corporation
Additional Description
The GB HIV Ag-Ab COMB assay is a 4th generation solid phase Enzyme-Linked Immunosorbent assay using a mixture of antigens and antibodies for the qualitative in vitro diagnostic screening in human serum or plasma of antibodies to HIV-1(group M and O), HIV-2 and HIV-1 p24 antigen.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105030404 | HIV MULTIPLE AG/AB COMBI TEST |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | 2116030CE04 | DEKRA Certification B.V. | Expired |
| IVDD Annex IV Section 4 | 2116030DE11 | DEKRA Certification B.V. | Expired |
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