26031

Organization name

DIESSE Diagnostica Senese S.p.A

SRN

IT-MF-000013311

Manufacturer status

Active

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

• CW008

  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.

Primary placement in Italy; available across 1 country total.

Trade name

not provided

UDI-DI code

08033891328412

Basic UDI-DI

803389132RPRD-A00YC

Reference / catalog number

26031

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

"RPR-DAT ADVANCED (REF 26031) is a non-treponemal agglutination assay for the qualitative and semi-quantitative detection of reagines in human serum to be applied to the AUTO-DAT (REF 26001) instrument. Because non-treponemal tests are based on the detection of reagines, a class of antibodies found in Syphilis (a disease caused by Treponema pallidum infection), the kit is intended to determine exposure to Treponema pallidum infection and to be used as an aid in its diagnosis. The test is not intended to be used to detect exposure to Treponema pallidum infection in blood, blood components, cells, tissues, organs, or any derivatives thereof in order to assess their suitability for transfusion, transplantation, or cell administration. It should only be used by professional laboratory personnel."

Additional information URL

No additional information URL provided by the manufacturer.

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.

• W0105010399SYPHILIS REAGENTS OTHER