Eu Ivdd
Eu Ivd Annex 2 List A
On The Market
🇹🇼 Taiwan
ANTISURASE B-96 (TMB)
Devices (same UDI-DI)
1
Certificates
2
Countries
0
Notified Bodies
2
Basic Information
- Primary DI
- 04712803531150
- Basic UDI-DI Code
- B-04712803531150
- Reference
- 4SBE3
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List A
- Status
- On The Market
- Manufacturer
- General Biologicals Corporation
Additional Description
ANTISURASE B-96 (TMB) is an enzyme immunoassay diagnostic kit for in vitro qualitative detection of Antibody to Hepatitis B surface antigen (Anti-HBs) in human serum or plasma (heparin, citrate or EDTA). The test can be used prior and after hepatitis B vaccination to assess the immune status as well as an aid to diagnose and monitor infections by hepatitis B virus.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105020203 | HEPATITIS B SURFACE ANTIBODY (TOTAL) |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV Section 4 | 2116030DE02 | DEKRA Certification B.V. | Expired |
| IVDD Annex IV (excluding sections 4, 6) | 2116030CE01 | DEKRA Certification B.V. | Expired |
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