Eu Ivdd
Eu Ivd Annex 2 List A
On The Market
🇹🇼 Taiwan
EASE BN-96 (TMB)
Devices (same UDI-DI)
1
Certificates
2
Countries
0
Notified Bodies
2
Basic Information
- Primary DI
- 04712803531181
- Basic UDI-DI Code
- B-04712803531181
- Reference
- 4BNE3
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List A
- Status
- On The Market
- Manufacturer
- General Biologicals Corporation
Additional Description
EASE BN-96 (TMB) is an enzyme immunoassay diagnostic kit, for in vitro qualitative testing HBeAg and Anti-HBe in human serum or plasma.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105020299 | HBV REAGENTS - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV Section 4 | 2116030DE06 | DEKRA Certification B.V. | Expired |
| IVDD Annex IV (excluding sections 4, 6) | 2116030CE01 | DEKRA Certification B.V. | Expired |
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