RE19011

Organization name

IBL International GmbH

SRN

DE-MF-000015709

Manufacturer status

Active

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

• CW010

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

  see IFU
• CW029

  in case of broken glas vials
• CW007

  see IFU
• CW028

  see IFU
• CW008

  contains biological material of human origin

Primary placement in Germany; available across 32 countries total.

Trade name

not provided

UDI-DI code

04049325030657

Basic UDI-DI

4049325IVR06020003BR7

Reference / catalog number

RE19011

Issuing entity

GS1

Risk category

IVDR Class B

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Radio immunoassay for the quantitative determination of antibodies against double stranded DNA (dsDNA) in adult human serum. The device is intended as an aid in the diagnosis of SLE in patients suspected of Systemic lupus erythematosus (SLE) disease, a systemic and clinically heterogeneous autoimmune disease characterized by autoantibody formation. The presence of anti-dsDNA-Ab is highly characteristic for patients with SLE. It is intended as an aid in the diagnosis of SLE, as well as for antibody quantification before and during disease and as a follow-up/monitoring e.g. of treatments and disease progression. The test kit is intended for manual and professional laboratory use by trained personnel. The test kit is not for home or layperson use.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0102100105DS DNA - ANTIBODIES

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