Eu Ivdd
Eu Ivd Annex 2 List A
On The Market
🇹🇼 Taiwan
HBV RealQuant™ PCR
Devices (same UDI-DI)
1
Certificates
2
Countries
0
Notified Bodies
2
Basic Information
- Primary DI
- 04712803530016
- Basic UDI-DI Code
- B-04712803530016
- Reference
- 4HBPA2
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List A
- Status
- On The Market
- Manufacturer
- General Biologicals Corporation
Additional Description
HBV RealQuant™ PCR is an in vitro nucleic acid amplification diagnostic kit developed by General Biologicals Corporation, Taiwan. It is intended for quantitative detection of hepatitis B DNA (viral load) in human serum or plasma. HBV RealQuant™ PCR is not intended for use as a screening test for blood or blood products for the presence of HBV or as a diagnostic test to confirm the presence of HBV infection.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105020299 | HBV REAGENTS - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV Section 4 | 2116030DE08 | DEKRA Certification B.V. | Expired |
| IVDD Annex IV (excluding sections 4, 6) | 2116030CE02 | DEKRA Certification B.V. | Expired |
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