86048

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.
• CW265

  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

08033891323332

Basic UDI-DI

803389132CHORUSCLPM009X

Reference / catalog number

86048

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 Cardiolipin-M (REF 86048 - 86048/12) is an immunoassay kit for the automated semi-quantitative determination of IgM antibodies against Cardiolipin, an acid phospholipid derived from glycerol. Since the detection of antibodies against Cardiolipin IgG and/or IgM is one of the Sydney criteria to define antiphospholipid syndrome (APS), the kit is used as an aid to the related diagnosis. The test, performed in human serum using a disposable device applied to the CHORUS/CHORUS TRIO/CHORUS EVO instruments, must be used by professional laboratory personnel 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.

• W0102100501ANTI-CARDIOLIPIN ANTIBODIES