LIOFeron® TB/LTBI

Organization name

Lionex GmbH

SRN

DE-MF-000038504

Manufacturer status

Active

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

• CW011

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

  EUDAMED did not publish a description for this code.
• CW009

  Do not re-use microtiter strips
• CW007

  EUDAMED did not publish a description for this code.
• CW032

  EUDAMED did not publish a description for this code.
• CW073

  Stop solution contains sulfuric acid.
• CW082

  Avoid direct contact with substrate solution.
• CW085

  Avoid direct contact with substrate solution and stop solution.
• CW096

  Avoid direct contact with substrate solution.

Primary placement in Germany; available across 32 countries total.

Trade name

LIOFeron® TB/LTBI

UDI-DI code

111761300821

Basic UDI-DI

PP07924LIOFERON0240

Reference / catalog number

LIOFeron 02_22

Issuing entity

IFA

Risk category

IVDR Class C

Applicable legislation

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

Status

On the market

Quantity

22

Additional product description

Interferon Gamma Release Assay for the detection of an infection with Mycobacterium tuberculosis.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W01030601INTERFERONS (α, β, ɣ…)

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