26001

Organization name

DIESSE Diagnostica Senese S.p.A

SRN

IT-MF-000013311

Manufacturer status

Active

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

• CW010

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

  EUDAMED did not publish a description for this code.

Primary placement in Italy; available across 1 country total.

Placed on the market in Italy; per-country availability dates not published.

Trade name

not provided

UDI-DI code

08033891328368

Basic UDI-DI

803389132AUTODAT2005Y

Reference / catalog number

26001

Issuing entity

GS1

Risk category

IVDR Class A

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

"AUTO-DAT is a semi-automatic instrument for the execution, interpretation and reporting of microplate agglutination serological tests. The instrument processes the images, taken from the instrument cameras, by evaluating the agglutination reactions that occurred in the microplate as a result of mixing and provides a qualitative or semiquantitative result, based on the analyzed test, using a specific software. Only materials supplied by DIESSE Diagnostica Senese S.p.A and intended for use with this instrument should be used for agglutination tests. This instrument is intended to be used only by professional laboratory users. It is prohibited to use AUTO-DAT for any activity unrelated to its intended use."

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.

• W0204INFECTIOUS IMMUNOLOGY INSTRUMENTS