9191EP

Organization name

Eurospital Spa

SRN

IT-MF-000028468

Manufacturer status

Active

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

• CW007

  In case of external damage to packaging, make sure that all components listed in the “Materials Provided” with the kit are present and undamaged. In the presence of liquid leakage from the vials or if the aluminium bag is damaged, the kit should not be used.
• CW129

  EUDAMED did not publish a description for this code.
• CW073

  EUDAMED did not publish a description for this code.
• CW082

  EUDAMED did not publish a description for this code.
• CW085

  EUDAMED did not publish a description for this code.
• CW167

  EUDAMED did not publish a description for this code.
• CW304

  EUDAMED did not publish a description for this code.
• CW225

  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

08028169208411

Basic UDI-DI

802816920BW01020608053R

Reference / catalog number

9191EP

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

Elafast is an in vitro diagnostic medical device. It is a rapid immunochromatographic assay based on anti-pancreatic elastase monoclonal antibodies. Pancreatic elastase present in the diluted fecal extract sample is bound by the gold nanoparticle-conjugate antibody. The so formed complex moves along the reaction strip and binds to the anti-elastase antibody present in the reaction area (T) while unbound antibodies bind in the control area (C). The concentration of pancreatic elastase in the sample is calculated by means of proprietary Eurospital rapid test readers CalFast® Reader and Eu-Fast Reader.

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.

• W0102069009ELASTASE (PANCREATIC POLYPEPTIDE)