Calprest ® NG-S

Organization name

Eurospital Spa

SRN

IT-MF-000028468

Manufacturer status

Active

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

• CW084

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Primary placement in Italy; available across 1 country total.

Trade name

Calprest ® NG-S

UDI-DI code

08028169207216

Basic UDI-DI

802816920BW01020608023K

Reference / catalog number

9069S

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

Calprest NG-S is a quantitative ELISA for detecting concentration of faecal calprotectin that is intended to aid in the diagnosis of Inflammatory Bowel Diseases (IBD), specifically Crohn’s disease and ulcerative colitis, and to differentiate IBD from Irritable Bowel Syndrome (IBS) in conjunction with other clinical and laboratory findings. Calprest NG-S is a quantitative ELISA for the determination of calprotectin in human serum or EDTA plasma in the assessment of the inflammatory status. Results are to be used in conjunction with other clinical and laboratory findings. The IVD medical device can be suitable to support diagnosis in general population. The device is intended for professional use 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.

• W0102019009CALPROTECTIN