a-AMYLASE

Primary DI

05204309171453

Basic UDI-DI Code

5204309000001NC

Reference

1415-0162

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class C

Status

On The Market

Manufacturer

Medicon Hellas SA

Reagent kit for In Vitro quantitative automated measurement by trained laboratory professionals of the activity of the enzyme α-Amylase (EC 3.2.1.1), in samples of human serum, heparinized plasma, or urine, from patients presenting with abdominal pain or other relevant physical, clinical and laboratory findings. Measurements of α-Amylase are intended to be used by licensed physicians, along with other in vitro and in vivo tests and physical examination, as an aid in the differential diagnosis and evaluation of abdominal pain, in conditions with pancreatic involvement. The device measures total amylase activity and cannot be used on its own, as the only test for evaluating pancreatitis, perforated peptic ulcer, mesenteric ischemia, and acute biliary obstruction.

The Basic UDI-DI associated with this device has 3 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 C) and regulation (EU IVDR).