Eu Ivdd Eu Ivd General On The Market

ADA

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

Basic Information

Primary DI
05204309151035
Basic UDI-DI Code
B-05204309151035
Reference
1417-0902
Device Types
None provided
Regulation
Eu Ivdd
Classification
Eu Ivd General
Status
On The Market
Manufacturer
Medicon Hellas SA

Additional Description

Reagent kit for In Vitro quantitative automated measurement by trained laboratory professionals of the activity of Adenosine Deaminase – ADA (EC 3.5. 4.4) in samples of human serum or pleuritic fluid from the general patient population. Measurements of ADA are to be used along with other in vitro and in vivo tests and physical examination by licensed physicians, for the investigation of pleural effusions and as an aid for diagnosis of tuberculous pleuritis. This device has not been tested for the screening, diagnosis, monitoring, management or other purposes related to ADA deficiency or deficiency of its isoenzymes. This product has been packed for use with Siemens ADVIA® 1800/2400/XPT chemistry analyzers.

CND Nomenclature Codes

Code Description
W01010199 ENZYMES - OTHER

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