Eu Ivdd
Eu Ivd Annex 2 List A
On The Market
🇹🇼 Taiwan
ANTICORASE MB-96 (TMB)
Devices (same UDI-DI)
1
Certificates
2
Countries
0
Notified Bodies
2
Basic Information
- Primary DI
- 04712803531174
- Basic UDI-DI Code
- B-04712803531174
- Reference
- 4CME3
- 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 MB-96 (TMB) is an enzyme immunoassay for in vitro qualitative detection of IgM antibody to hepatitis B virus core antigen (Anti-HBc IgM) in human serum or plasma (heparin, EDTA or citrate).
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105020210 | HEPATITIS B CORE ANTIBODY IGM |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | 2116030CE01 | DEKRA Certification B.V. | Expired |
| IVDD Annex IV Section 4 | 2116030DE04 | DEKRA Certification B.V. | Expired |
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