Eu Ivdd Eu Ivd General On The Market 🇫🇮 Finland

ReaScan TBE IgM

Reagena Oy · 🇫🇮 Finland
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
D-114106LU
Basic UDI-DI Code
B-114106LU
Reference
114106
Device Types
None provided
Regulation
Eu Ivdd
Classification
Eu Ivd General
Status
On The Market
Manufacturer
Reagena Oy

Additional Description

ReaScan TBE IgM is a rapid test for qualitative detection of tick-borne encephalitis (TBE, FSME) virus specific IgM antibodies in human serum and cerebrospinal fluid (CSF). The test result is read from the Test cassette with the ReaScan+ reader (REF 105100) (Reagena Oy, Toivala, Finland). The result is used as an aid in the diagnosis of TBE.

CND Nomenclature Codes

Code Description
W0105099099 VIROLOGY - RT & POC - OTHER

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