82308

Organization name

DIESSE Diagnostica Senese S.p.A

SRN

IT-MF-000013311

Manufacturer status

Active

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

• CW011

  EUDAMED did not publish a description for this code.
• CW008

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

  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.
• CW083

  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

08033891322779

Basic UDI-DI

803389132CCAB-C0099

Reference / catalog number

82308

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 CLIA CLOSTRIDIUM DIFFICILE A/B TOXINS is an immunoassay kit for the qualitative automated determination of Clostridium difficile A/B toxins. The test is performed on human feces using a disposable device applied on instrument CHORUS EVO. The kit is intended to confirm exposure to infection by C. difficile as an aid to related diagnosis of infection. Consequently, the target population consists of patients suspected of being affected by C. difficile infection. The kit must 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.

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

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

• W0105011802C.DIFFICILE TOXIN A/B DETECTION