Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- D-115103LV
- Basic UDI-DI Code
- B-115103LV
- Reference
- 115103
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Reagena Oy
Additional Description
ReaScan+ LYME IgM/IgG Combo is an immunochromatographic rapid test intended for the qualitative detection of Borrelia burgdorferi specific IgM and IgG antibodies in human serum and cerebrospinal fluid (CSF). The test result is read from the test cassette with the ReaScan+ reader (105100, Oy Reagena Ltd, Finland). The result is used as an aid in diagnosis of Lyme borreliosis (LB).
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105090199 | BACTERIOLOGY - RT & POC - OTHER |
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