81252

Organization name

DIESSE Diagnostica Senese S.p.A

SRN

IT-MF-000013311

Manufacturer status

Active

7 warnings recorded — scroll inside the panel to see all entries.

• CW011

  EUDAMED did not publish a description for this code.
• CW008

  EUDAMED did not publish a description for this code.
• CW265

  EUDAMED did not publish a description for this code.
• CW010

  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.
• CW076

  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

08033891328610

Basic UDI-DI

803389132CHORUSCHA003Z

Reference / catalog number

81252

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 CHLAMYDOPHILA PNEUMONIAE IGA (REF 81252) is an immunoassay kit for the automated semi-quantitative determination of IgA antibodies against Chlamydophila pneumoniae. The kit is intended to detect exposure to bacterium as an aid to the related diagnosis. Accordingly, the testing population is represented by patients with suspected Chlamydophila pneumoniae infection. 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.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W0105010114CHLAMYDIA PNEUMONIAE ANTIBODY IGA