TR004.2-250IC

Organization name

Hain Lifescience GmbH

SRN

DE-MF-000008606

Manufacturer status

Active

4 warnings recorded — scroll inside the panel to see all entries.

• CW008

  EUDAMED did not publish a description for this code.
• CW011

  EUDAMED did not publish a description for this code.
• CW010

  EUDAMED did not publish a description for this code.
• CW263

  EUDAMED did not publish a description for this code.

Primary placement in France; available across 10 countries total.

Trade name

not provided

UDI-DI code

04049055003891

Basic UDI-DI

40490550300001100TU

Reference / catalog number

TR004.2-250IC

Issuing entity

GS1

Risk category

IVDR Class D

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product 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.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0105020216HEPATITIS B VIRUS - NA REAGENTS

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

Certificate health across this manufacturer's portfolio.