Eu Ivdd
Eu Ivd Annex 2 List A
On The Market
🇹🇼 Taiwan
ANTICORASE B-96 (TMB)
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 04712803531167
- Basic UDI-DI Code
- B-04712803531167
- Reference
- 4CBE3
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List A
- Status
- On The Market
- Manufacturer
- General Biologicals Corporation
Additional Description
ANTICORASE B-96 (TMB) is an enzyme immunoassay for in vitro qualitative detection of total antibody to hepatitis B virus core antigen (Anti-HBc total) in human serum or plasma (heparin, EDTA or citrate).
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105020209 | HEPATITIS B CORE ANTIBODY IGG |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | 2116030CE01 | DEKRA Certification B.V. | Expired |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Annex 2 List A) and regulation (EU IVDD).
Multiple Rapid TP/HIV Test
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·MedMira Laboratories Inc.·On the market
Multiplo Rapid TP/HIV Test
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·MedMira Laboratories Inc.·On the market
Multiplo Rapid TP/HIV Test
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·MedMira Laboratories Inc.·On the market
Reveal Rapid HIV Test
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·MedMira Laboratories Inc.·On the market
Reveal Rapid HIV Test
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·MedMira Laboratories Inc.·On the market
Reveal Rapid HIV Test
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·MedMira Laboratories Inc.·On the market