Eu Ivdd
Eu Ivd Annex 2 List A
On The Market
🇹🇼 Taiwan
ANTISURGEN B
Devices (same UDI-DI)
1
Certificates
2
Countries
0
Notified Bodies
2
Basic Information
- Primary DI
- 04712803531211
- Basic UDI-DI Code
- B-04712803531211
- Reference
- 4SAO
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List A
- Status
- On The Market
- Manufacturer
- General Biologicals Corporation
Additional Description
ANTISURGEN B is a test kit for confirmation the existence of HBsAg in the specimens. When ANTISURGEN B is used in combination with SURASE B-96 (TMB), it can confirm the presence or absence of HBsAg in specimens which are positive for HBsAg in screening test.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105020202 | HEPATITIS B SURFACE ANTIGEN - CONFIRMATORY |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV Section 4 | 2116030DE09 | DEKRA Certification B.V. | Expired |
| IVDD Annex IV (excluding sections 4, 6) | 2116030CE01 | DEKRA Certification B.V. | Expired |
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