86034

Organization name

DIESSE Diagnostica Senese S.p.A

SRN

IT-MF-000013311

Manufacturer status

Active

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• CW008

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

  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.
• 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

08033891327408

Basic UDI-DI

803389132CHORUSDSDNAM00V6

Reference / catalog number

86034

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 dsDNA-M (REF 86034 - 86034/12) is an immunoassay kit for automated semiquantitative determination of IgM class antibodies against dsDNA. As dsDNA antibodies are widely used as a serologic marker of systemic lupus erythematosus (SLE), the kit is used as an aid to related diagnosis and clinical monitoring. The test, performed in human serum using a disposable device applied to the CHORUS and CHORUS TRIO instruments, must be used by professional laboratory users only."

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.

• W0102100105DS DNA - ANTIBODIES