Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- D-115105LZ
- Basic UDI-DI Code
- B-115105LZ
- Reference
- 115105
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Reagena Oy
Additional Description
ReaScan+ PUUMALA IgM is an immunochromatographic rapid test intended for the qualitative detection of Puumala virus specific IgM antibodies from human serum and plasma. ReaScan+ PUUMALA IgM result is used as an aid in the diagnosis of acute Puumala virus infection, nephropathia epidemica (NE). The test result is read from the test cassette with ReaScan+ reader (105100, Reagena Oy, Toivala, Finland).
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105099099 | VIROLOGY - RT & POC - OTHER |
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