AMMONIA

Primary DI

16970301471018

Basic UDI-DI Code

B-16970301471018

Reference

EGSAMM

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Beijing Strong Biotechnologies, Inc.

INTENDED USE：For in vitro quantitative determination of ammonia in plasma. CLINICAL SIGNIFICANCE：Under normal circumstances, ammonia converts to urea in the liver. With severe liver disease, ammonia cannot be converted and eliminated from the circulation, which in turn causes blood ammonia increase. High blood ammonia is neurotoxic, and will lead hepatic encephalopathy (hepatic coma). Adult plasma ammonia determination mainly use for monitoring and treatment of hepatic coma.In addition, plasma ammonia determination can be used in pediatric diagnosis of Reye's syndrome.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).