86024/12

Trade name

not provided

UDI-DI code

08033891329167

Basic UDI-DI

803389132CHORUSSSB00C3

Reference / catalog number

86024/12

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

CHORUS SS-B (REF 86024-86024/12) is an immunoassay kit for the automated semiquantitative determination of anti-SS-B IgG antibodies. The test is performed in human serum using a disposable device applied on CHORUS/CHORUS TRIO/CHORUS EVO instruments. Since SS-B antibodies are typical markers for Sjögren’s syndrome (SS) and systemic lupus erythematosus (SLE), the kit is used as an aid to their diagnosis. Accordingly, the testing population is represented by patients suspected to be affected by these systemic autoimmune diseases. The test is to be used only by properly trained professional laboratory personnel.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

• W0102100113SS-B

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

• CW008

  EUDAMED did not publish a description for this code.
• CW265

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

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

  EUDAMED did not publish a description for this code.
• CW083

  EUDAMED did not publish a description for this code.

No certificate specifically references this device's Basic UDI-DI.