82304

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

08033891328474

Basic UDI-DI

803389132CFEL005H

Reference / catalog number

82304

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 FECAL ELASTASE (REF 82304) is an immunoenzymatic assay kit for the automated quantitative determination of human fecal pancreatic elastase using a disposable device applied on the CHORUS EVO instruments. Since the measurement of pancreatic elastase in feces has assumed an important role in the diagnosis of pancreatic insufficiency, the kit is intended to be used as an aid in the related diagnosis and subsequent monitoring. 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.

• W0102069009ELASTASE (PANCREATIC POLYPEPTIDE)