Basic Information
- Primary DI
- 111745456742
- Basic UDI-DI Code
- B-111745456742
- Reference
- DTO2
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Te?ted Oy
Additional Description
The TICKPLEX® PLUS test provides a quantitative and qualitative in vitro assay for human IgM and IgG antibodies against multiple microbial antigens in human serum or plasma. The kit tests for Borrelia afzelii, Borrelia burgdorferi, and Borrelia garinii infections and the tests include persistent antigens of the different Borrelia species. In addition, the kit tests for co-infections (Babesia microti, Bartonella henselae, Ehrlichia chaffeensis, Rickettsia akari), and opportunistic infections (Coxsackievirus, Epstein-Barr virus, Human parvovirus B19, Mycoplasma fermentans and Mycoplasma pneumoniae) associated with tick-borne diseases. This kit is intended to aid in diagnosis of tick-borne pathogen infections. The test kit and TICKPEX® PLUS analyze excel sheet are intended to aid in the diagnosis of diseases associated with a tick bite. The test kit and TICKPEX® PLUS analyze excel sheet are for professional use only in clinical laboratory environment and are not to be used for self-testing.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102010107 | IMMUNOGLOBULIN M |
| W0102010105 | IMMUNOGLOBULIN G |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).