Basic Information
- Primary DI
- 06419587343006
- Basic UDI-DI Code
- 6419587RNT0103T
- Reference
- 740450
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class A
- Status
- On The Market
- Manufacturer
- Biohit Oyj
Additional Description
GP Reader NT is an automated instrument for the quantitative determination of various analytes in human samples, such as whole blood, plasma or fecal samples, by measuring fluorescence signals from lateral flow test cassettes. GP Reader NT is intended for use with compatible fluorimetric lateral flow immunoassay (FLFIA) test kits, such as GastroPanel quick test NT (REF 602410 and REF 602420), as an aid in the diagnosis, screening, or monitoring of medical conditions, as specifically defined, along with the characteristics of the testing population, required specimen, and detected analyte, in the intended purpose of the individual test kit it is used with. GP Reader NT is intended to be used by healthcare professionals, either in a laboratory or near-patient setting. For in vitro diagnostic use.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0201069099 | VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Class A) and regulation (EU IVDR).