SpotSight® scan
Intended use:Evaluation software for SeraSpot® arrays FilesDear customers, we have started to provide the documents for our products in an electronic format. These are the Instructions for Use [...]
Dear customers,
we have started to provide the documents for our products in an electronic format. These are the Instructions for Use (IFU), the Safety Data Sheets (SDS) and the Certificate of Analysis (CoA). For batches placed on the market after 01 January 2023, you can find our documents on the eIFU portal https://eifu.r-biopharm.com.
SeraSpot® Anti-Borrelia-10 IgG / IgM
Intended use:The SeraSpot® Anti-Borrelia-10 IgG / SeraSpot® Anti-Borrelia-10 IgM test is an in vitro diagnostic device (spotimmunoassay, SIA) for the detection of Borrelia-specific IgG or IgM [...]
SeraSpot® Anti-Treponema-4 IgG / IgM
Intended use:The SeraSpot® Anti-Treponema-4 IgG / SeraSpot® Anti-Treponema-4 IgM is an in vitro diagnostic device (spotimmunoassay, SIA) for the detection of Treponema pallidum-specific IgG or [...]
SeraSpot® ANA-17 IgG
Intended use:The SeraSpot® ANA-17 IgG is an in vitro diagnostic device for the detection of antinuclear (ANA) and cytoplasmic antibodies of the IgG isotype directed against the following [...]
SeraSpot® Vaskulitis-3 IgG
Intended use:SeraSpot® Vaskulitis-3 IgG is an in vitro diagnostic device (spotimmunoassay, SIA) for the detection of autoantibodies of the IgG isotype directed against the following antigens: [...]
SeraSpot® HepAk-7 IgG
Intended use:The SeraSpot® HepAk-7 IgG test is an in vitro diagnostic device for the detection of autoantibodies of the IgG isotype of the following antigens: AMA-M2, LKM1, LC1, SLA, F-Aktin, [...]
RIDASCREEN® VDZ Monitoring
Intended use:The RIDASCREEN® VDZ Monitoring is an enzyme linked immunosorbent assay intended for the quantitative determination of vedolizumab (VDZ, Entyvio®, anti- integrin α4β7) in human serum [...]