81176

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.

• CW008

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

  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

08033891324094

Basic UDI-DI

803389132CHORUSWNM00E3

Reference / catalog number

81176

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 WEST NILE VIRUS IgM is an immunological kit for the automated qualitative determination of IgM class antibodies against West Nile Virus (WNV). The test is performed on human serum using a disposable device applied on the CHORUS/ CHORUS TRIO/ CHORUS EVO instruments. The kit is intended to detect exposure to WNV infection as an aid in its diagnosis. Accordingly, the target population is represented by patients suspected to be affected by West Nile Virus infection. 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.

• W0105040626WEST NILE VIRUS