GENERIC HBV VIRAL LOAD VER 2.0
Basic Information
- Primary DI
- 04049055003891
- Basic UDI-DI Code
- 40490550300001100TU
- Reference
- TR004.2-250IC
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class D
- Status
- On The Market
- Manufacturer
- Hain Lifescience GmbH
Additional Description
GENERIC HBV VIRAL LOAD VER 2.0 assay is a semi-automated in vitro polymerase chain reaction (PCR) assay for the quantification of hepatitis B virus (HBV) DNA in human EDTA plasma from HBV-infected patients. The assay is indicated for use by laboratory professionals using the compatible devices. The results must be interpreted within the context of all relevant clinical and laboratory findings. This device is not intended to be used to detect the presence of, or exposure to, or for screening for HBV in blood, blood components, cells, tissues, organs, or any of their derivatives in order to assess their suitability for transfusion, transplantation, or cell administration.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105020216 | HEPATITIS B VIRUS - NA REAGENTS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDR Technical Documentation | V70 079456 0010 | TÜV SÜD Product Service GmbH |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Class D) and regulation (EU IVDR).