Eu Ivdr Eu Ivd Class B On The Market

LDH P-L

Devices (same UDI-DI)
2
Certificates
0
Countries
2
Notified Bodies
0

Basic Information

Primary DI
05204309039869
Basic UDI-DI Code
5204309000034NT
Reference
1418-0117
Device Types
None provided
Regulation
Eu Ivdr
Classification
Eu Ivd Class B
Status
On The Market
Manufacturer
Medicon Hellas SA

Additional Description

Reagents for In Vitro quantitative automated determination of the activity of Lactate Dehydrogenase – LDH (EC 1.1.1.27) in samples of human serum, plasma, or cerebrospinal fluid from the general patient population. Measurements of LDH are to be used along with other in vitro and in vivo tests and physical examination by licensed physicians as an aid for screening, diagnosis and management of conditions related to cell damage. 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.

CND Nomenclature Codes

Code Description
W01010120 LACTATE DEHYDROGENASE P ( LDH - P --> L )

Available In Countries

🇧🇬 Bulgaria 🇬🇷 Greece

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