86052/12

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

08033891329303

Basic UDI-DI

803389132CHORUSBGM005B

Reference / catalog number

86052/12

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 Beta 2-Glycoprotein-M (REF 86052 - 86052/12) is an immunoassay kit for automated semi-quantitative determination of IgM class antibodies against β2-Glicoproteina I. The test performed in human serum, using a disposable device applied on the CHORUS/CHORUS TRIO /CHORUS EVO instruments. Since the detection of antibodies against β2-glycoprotein I is one of the Sydney criteria, used to define antiphospholipid syndrome (APS), the kit is used as an aid to the related diagnosis. Consequently, the target population consists of patients suspected of being affected by antiphospholipid syndrome (APS). It is to be used only 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.

• W0102100503ANTI-B2-GLYCOPROTEIN I ANTIBODIES