26041

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

08033891328429

Basic UDI-DI

803389132TPHAD00ND

Reference / catalog number

26041

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

"TPHA-DAT ADVANCED (REF 26041) is a hemagglutination test for the semi-quantitative detection of specific antibodies directed against Treponema pallidum. The test is performed on human serum by passive hemagglutination using the AUTO-DAT instrument (REF 26001). The kit is intended to determine exposure to Treponema pallidum infection and to be used as an aid in the diagnosis of Syphilis. The test is not intended to be used to detect exposure to Treponema pallidum infection in blood, blood components, cells, tissues, organs, or any derivative thereof for the purpose of assessing their suitability for transfusion, transplantation, or cell administration. It should be used only 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.

• W0105010302SYPHILIS ANTIBODY ASSAYS TOTAL