82300

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

08033891328511

Basic UDI-DI

803389132CCALP009X

Reference / catalog number

82300

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 CLIA CALPROTECTIN is an immunoassay kit for the automated quantitative determination of Calprotectin in stools. The test is performed on feces using a disposable device attached to the CHORUS EVO. High concentration of Calprotectin is observed in the feces of patients with chronic inflammatory diseases (IBD). The kit, intended for the determination of Calprotectin concentration is used as an aid to diagnosis and management of related therapeutic measures. 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.

• W0102019009CALPROTECTIN