Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- D-114313M3
- Basic UDI-DI Code
- B-114313M3
- Reference
- 114313
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Reagena Oy
Additional Description
ReaScan+ C6 LYME IgG test is an immunochromatographic rapid test intended for qualitative detection of Borrelia burgdorferi specific IgG antibodies in human serum and cerebrospinal fluid (CSF). The result is used as an aid in diagnosis of Lyme borreliosis (LB). The test result is read from the test cassette with the ReaScan+ reader (105100, Reagena Oy, Finland).
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105090199 | BACTERIOLOGY - RT & POC - OTHER |
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