622120

Organization name

QIAGEN GmbH

SRN

DE-MF-000004949

Manufacturer status

Active

Certificate health across this manufacturer's portfolio.

1 warning recorded — scroll inside the panel to see all entries.

• CW018

  EUDAMED did not publish a description for this code.

Primary placement in Austria; available across 32 countries total.

Trade name

not provided

UDI-DI code

04053228022107

Basic UDI-DI

4053228RTBQFT0000000001W8

Reference / catalog number

622120

Issuing entity

GS1

Risk category

IVDR Class C

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The QuantiFERON-TB Gold Plus (QFT-Plus) assay is an in vitro diagnostic test using a peptide cocktail simulating ESAT-6 and CFP-10 proteins to stimulate cells in heparinized whole blood. Detection of interferon-γ (IFN-γ) by enzyme-linked immunosorbent assay (ELISA) is used to identify in vitro responses to those peptide antigens that are associated with Mycobacterium tuberculosis infection.

Additional information URL

https://www.qiagen.com/

Clinical sizes

No clinical sizes registered for this device.

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

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W0105010704TB-IGRA (INTERFERON-‐GAMMA-‐RELEASE ASSAY)