Eu Ivdd Eu Ivd General On The Market

CYSTATIN C

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

Basic Information

Primary DI
05204309152292
Basic UDI-DI Code
B-05204309152292
Reference
1418-0596
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 concentration of Cystatin C – CysC in samples of human serum or plasma from the general patient population. Measurements of CysC are to be used along with other in vitro and in vivo tests and physical examination by licensed physicians, as an aid for diagnosis and management of renal disease. 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
W0102019008 CYSTATIN C

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