86012

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

08033891323134

Basic UDI-DI

803389132CHORUSENA6S00BK

Reference / catalog number

86012

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 ENA-6 S is an immunoassay kit for the automated qualitative determination of IgG class antibodies against 6 cellular and nuclear antigens (SS-A, SS-B, Scl-70, Sm, snRNP/Sm and Jo-1). As ENA antibodies are widely used as a serologic marker of systemic autoimmune rheumatic disease, the kit is used as an aid to related diagnosis. The test performed in human serum, using a disposable device applied on 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.

• W0102100102ENA SCREENING