Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- D-114403M5
- Basic UDI-DI Code
- B-114403M5
- Reference
- 114403
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Reagena Oy
Additional Description
Reagena C6 LYME IgM/IgG EIA is an enzyme immunoassay intended for the qualitative detection of Borrelia burgdorferi specific IgM and IgG antibodies in human serum and cerebrospinal fluid (CSF). The result is used as an aid in diagnosis of Lyme borreliosis (LB).
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105010602 | LYME ANTIBODY TOTAL |
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