A1-ANTITRYPSIN (PROTEASE INHIBITOR)

Primary DI

04049095070037

Basic UDI-DI Code

4049095G090340000RW

Reference

G09034

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class B

Status

On The Market

Manufacturer

R-Biopharm AG

For in vitro diagnostic use. The RIDASCREEN® α1-Antitrypsin test is a manual enzyme immunoassay for the quantitative detection of human α1-Antitrypsin in untreated human stool samples. The RIDASCREEN® α1-Antitrypsin test is intended to support the diagnosis and treatment of (chronic) inflammatory bowel diseases and protein-losing enteropathy, along with other clinical and laboratory findings. The test results should not be used as the sole basis for diagnosis. The product is intended for professional use.

The Basic UDI-DI associated with this device has 2 devices in total. Below are some other devices sharing the same Basic UDI-DI.

Other on-the-market devices with the same classification (Eu Ivd Class B) and regulation (EU IVDR).