CHOLINESTERASE

Primary DI

05204309039876

Basic UDI-DI Code

B-05204309039876

Reference

1418-0267

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Medicon Hellas SA

Reagents for In Vitro quantitative automated determination of the activity of Cholinesterase - CHE (EC 3.1.1.7) in samples of human serum or plasma from the general patient population. Measurements of CHE are to be used along with other in vitro and in vivo tests and physical examination by licensed physicians, as an aid for diagnosis of liver and heart related disorders and, preoperatively, for identification of patients with increased sensitivity to certain anesthetic drugs. This product has been packed for use with BECKMAN COULTER AU series chemistry analyzers (AU600, AU600IVD, AU400, AU640, AU2700, AU5400, AU480, and AU680). For in vitro diagnostic use only by trained laboratory professionals.

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