CE-IVD
IVDR marking
Micro Solutions / Life Science
ZytoLight and chromogenic ZytoDot probes for HER2, ALK, ROS1 and other markers
ZytoLight and chromogenic ZytoDot probes for HER2, ALK, ROS1 and other markers
Finished sets for FISH and CISH on FFPE-sections and cytology, CE-IVD
ZytoLight and ZytoDot probes from ZytoVision give the laboratory a ready-made tool for fluorescent and chromogenic hybridization in situ in the diagnosis of HER2, ALK, ROS1 and other markers.
ZytoLight probes carry a direct fluorescent tag and do not require additional antibody detection; the line includes Dual Color, Break Apart, Dual Fusion, Triple/Quadruple Color and TriCheck formats for tissue slices and cytological preparations. ZytoDot and ZytoDot 2C probes are labeled with digoxygenin and detected chromogenically, which allows analysis of tissue sections and cytologic drugs. result in a conventional light microscope without fluorescent equipment.
The implementation kit for fabric (FISH-Tissue) and cytology (FISH-Cytology) contain pretritment solutions, wash buffers and DAPI/DuraTect solution required for the full FISH protocol. ZytoDot CISH Implementation Kit is designed for 40 tests and is used in conjunction with ZytoDot digoxygenin-labeled probes on FFPE samples. CE-IVD sets They are labeled in accordance with IVDR (EU) 2017/746 and are intended for use in a certified pathomorphology laboratory under the supervision of a physician.
IVDR marking
tissue
| Probe format | ZytoLight - direct fluorescent tag; ZytoDot/ZytoDot 2C - chromogenic detection digoxygenin tag (CISH) |
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| Key targets | ERBB2/HER2, ALK, ROS1 and other markers of solid tumors |
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| Type of sample | FFPE tissue and cytological preparations |
| Registry | CE-IVD by IVDR (EU) 2017/746 |
| ZytoLight FISH-Tissue Implementation Kit | Pretritment solutions, wash buffers, DAPI/DuraTect - for tissue sections |
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| ZytoLight FISH-Cytology Implementation Kit | same composition in execution for cytological preparations |
| ZytoDot CISH Implementation Kit | 40 tests for ZytoDot digoxygenin-labeled probes |