Eu Ivdd Eu Ivd General On The Market

CHOLINESTERASE

Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
05204309167425
Basic UDI-DI Code
B-05204309167425
Reference
1415-0260
Device Types
None provided
Regulation
Eu Ivdd
Classification
Eu Ivd General
Status
On The Market
Manufacturer
Medicon Hellas SA

Additional Description

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 Abbott ARCHITECT® c4000/c8000/c16000 analyzers. For in vitro diagnostic use only by trained laboratory professionals.

CND Nomenclature Codes

Code Description
W01010111 CHOLINESTERASE

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