Manufacturer

ZytoVision

GermanyLegal entities : ZytoVision GmbH

Markets : Germany · United States

Approvals : EU – class A, C · United States (FDA) – · class I

5 categories, 319 models including 319 on the market, 1 country

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
DNA in situ hybridisation reagents	W01030703	Aura Probe BCL2 Break Apart FISH Aura Probe BCL6 Break Apart FISH Aura Probe ERBB2/CEN 17 FISH Aura Probe MET/CEN 7 FISH Aura Probe MYC Break Apart FISH 209 others FlexISH ALK/ROS1 DistinguISH Probe2 refs FlexISH BCL2/BCL6 DistinguISH Probe2 refs FlexISH ERBB2/CEN 17 Dual Color Probe2 refs FlexISH MYC/IGH TriCheck Probe FlexISH NTRK1/NTRK3 DistinguISH Probe2 refs98/79 FlexISH RET/KIF5B TriCheck Probe VisionArray HPV Chip 1.02 refs98/79 VisionArray HPV PreCise Master Mix98/79 VisionArray MYCO Chip 2.02 refs98/79 VisionArray MYCO PreCise Master Mix 2.098/79 ZytoDot 2C Glioma 1p/19q Probe Set2 refs ZytoDot 2C SPEC 19q13/19p13 Probe2 refs ZytoDot 2C SPEC 1p36/1q25 Probe2 refs ZytoDot 2C SPEC ALK Break Apart Probe2 refs ZytoDot 2C SPEC BCL2 Break Apart Probe ZytoDot 2C SPEC BCL6 Break Apart Probe ZytoDot 2C SPEC CDK4/CEN 12 Probe ZytoDot 2C SPEC CDKN2A/CEN 9 Probe98/79 ZytoDot 2C SPEC DDIT3 Break Apart Probe ZytoDot 2C SPEC EGFR/CEN 7 Probe2 refs ZytoDot 2C SPEC ERBB2/CEN 17 Probe2 refs ZytoDot 2C SPEC ERBB2/CEN 17 Probe Kit2 refs ZytoDot 2C SPEC EWSR1 Break Apart Probe ZytoDot 2C SPEC FGFR2/CEN 10 Probe ZytoDot 2C SPEC IGH Break Apart Probe ZytoDot 2C SPEC MDM2/CEN 12 Probe2 refs ZytoDot 2C SPEC MET/CEN 7 Probe ZytoDot 2C SPEC MYC Break Apart Probe ZytoDot 2C SPEC RET Break Apart Probe ZytoDot 2C SPEC ROS1 Break Apart Probe2 refs ZytoDot 2C SPEC SS18 Break Apart Probe ZytoDot 2C SPEC USP6 Break Apart Probe ZytoDot SPEC ERBB2 Probe ZytoDot SPEC ERBB2 Probe Kit ZytoDot SPEC MDM2 Probe ZytoDot SPEC MYCN Probe ZytoFast EBV Probe ZytoFast HPV High-Risk (HR) Types Probe ZytoFast HPV Screening Probe98/79 ZytoFast HPV type 16/18 Probe ZytoFast HPV type 31/33 Probe ZytoFast HPV type 6/11 Probe ZytoFast human lg-kappa Probe ZytoFast human lg-kappa/lg-lambda CISH Kit ZytoFast human lg-kappa/lg-lambda Permanent CISH Kit ZytoFast human lg-kappa/lg-lambda Probe ZytoFast human lg-lambda Probe ZytoLight Aneuploidy Panel 18/X/Y and 13/2198/79 ZytoLight Aneuploidy Panel X/Y and 13/18/212 refs98/79 ZytoLight Bladder Cancer Quadruple Color Probe2 refs98/79 ZytoLight CEN 11 Probe98/79 ZytoLight CEN 12 Probe98/79 ZytoLight CEN 17/SPEC ERBB2 Dual Color Probe2 refs ZytoLight CEN 8 Probe2 refs ZytoLight CEN X/Y Dual Color Probe98/79 ZytoLight CEN X/Yq12 Dual Color Probe2 refs98/79 ZytoLight Glioma 1p/19q Probe Set ZytoLight SPEC 11q gain/loss Triple Color Probe ZytoLight SPEC 13/21 Dual Color Probe98/79 ZytoLight SPEC 13/CEN 18/SPEC 21 Triple Color Probe2 refs98/79 ZytoLight SPEC 18/CEN X/Y Triple Color Probe98/79 ZytoLight SPEC 19q13/19p13 Dual Color Probe2 refs ZytoLight SPEC 1p36/1q25 Dual Color Probe2 refs ZytoLight SPEC 21/CEN X/Yq12 Triple Color Probe98/79 ZytoLight SPEC 4p11/CEN 10/17 Triple Color Probe ZytoLight SPEC ABL1 Dual Color Break Apart Probe ZytoLight SPEC ABL2 Dual Color Break Apart Probe ZytoLight SPEC ALK Dual Color Break Apart Probe2 refs ZytoLight SPEC ALK/2q11 Dual Color Probe ZytoLight SPEC ALK/EML4 TriCheck Probe2 refs ZytoLight SPEC Angelman Dual Color Probe98/79 ZytoLight SPEC ATM/CEN 11 Dual Color Probe ZytoLight SPEC ATM/CEN 12 Dual Color Probe ZytoLight SPEC BCL2 Dual Color Break Apart Probe2 refs ZytoLight SPEC BCL2/IGH Dual Color Dual Fusion Probe2 refs ZytoLight SPEC BCL6 Dual Color Break Apart Probe2 refs ZytoLight SPEC BCOR Dual Color Break Apart Probe98/79 ZytoLight SPEC BCR/ABL1 Dual Color Dual Fusion Probe2 refs ZytoLight SPEC BIRC3/MALT1 Dual Color Dual Fusion Probe2 refs98/79 ZytoLight SPEC BRAF Dual Color Break Apart Probe ZytoLight SPEC BRAF/CEN 7 Dual Color Probe ZytoLight SPEC C19MC/19p13 Dual Color Probe ZytoLight SPEC CBFB Dual Color Break Apart Probe ZytoLight SPEC CCND1 Break Apart/2q11/CEN 6 Quadruple Color Probe ZytoLight SPEC CCND1 Dual Color Break Apart Probe2 refs ZytoLight SPEC CCND1/CEN 11 Dual Color Probe2 refs ZytoLight SPEC CCND1/IGH Dual Color Dual Fusion Probe2 refs ZytoLight SPEC CD274,PDCD1LG2/CEN 9 Dual Color Probe2 refs ZytoLight SPEC CDK4/CEN 12 Dual Color Probe2 refs ZytoLight SPEC CDKN2A/CEN 3/7/17 Quadruple Color Probe2 refs ZytoLight SPEC CDKN2A/CEN 9 Dual Color Probe2 refs ZytoLight SPEC CIC Dual Color Break Apart Probe ZytoLight SPEC CKS1B/CDKN2C Dual Color Probe2 refs ZytoLight SPEC COL1A1 Dual Color Break Apart Probe ZytoLight SPEC COL1A1/PDGFB Dual Color Dual Fusion Probe2 refs ZytoLight SPEC CREBBP Dual Color Break Apart Probe98/79 ZytoLight SPEC CRLF2 Dual Color Break Apart Probe98/79 ZytoLight SPEC CSF1R Dual Color Break Apart Probe98/79 ZytoLight SPEC CSF1R/D5S23,D5S721 Dual Color Probe98/79 ZytoLight SPEC CUX1/EZH2/CEN 7 Triple Color Probe ZytoLight SPEC D13S319/13q34 Dual Color Probe2 refs ZytoLight SPEC D13S319/13q34/CEN 12 Triple Color Probe2 refs ZytoLight SPEC DDIT3 Dual Color Break Apart Probe2 refs ZytoLight SPEC DiGeorge Triple Color Probe98/79 ZytoLight SPEC DiGeorge/Phelan McDermid Dual Color Probe98/79 ZytoLight SPEC EGFR/CEN 7 Dual Color Probe2 refs ZytoLight SPEC EGR1/D5S23,D5S721 Dual Color Probe ZytoLight SPEC ERBB2/CEN 17 Dual Color Probe2 refs ZytoLight SPEC ERBB2/CEN 17 Dual Color Probe Kit2 refs ZytoLight SPEC ERBB2/D17S122 Dual Color Probe2 refs ZytoLight SPEC ERBB2/TOP2A/CEN 17 Triple Color Probe2 refs ZytoLight SPEC ERG Dual Color Break Apart Probe ZytoLight SPEC ERG/TMPRSS2 TriCheck Probe ZytoLight SPEC ESR1/CEN 6 Dual Color Probe ZytoLight SPEC ETV6 Dual Color Break Apart Probe2 refs ZytoLight SPEC ETV6/RUNX1 Dual Color Dual Fusion Probe2 refs98/79 ZytoLight SPEC EWSR1 Dual Color Break Apart Probe2 refs ZytoLight SPEC EWSR1/FLI1 TriCheck Probe ZytoLight SPEC FGFR1 Dual Color Break Apart Probe2 refs ZytoLight SPEC FGFR1/CEN 8 Dual Color Probe2 refs ZytoLight SPEC FGFR2 Dual Color Break Apart Probe2 refs ZytoLight SPEC FGFR2/CEN 10 Dual Color Probe ZytoLight SPEC FGFR3 Dual Color Break Apart Probe2 refs ZytoLight SPEC FGFR3/4p11 Dual Color Probe ZytoLight SPEC FGFR3/IGH Dual Color Dual Fusion Probe98/79 ZytoLight SPEC FOXO1 Dual Color Break Apart Probe2 refs ZytoLight SPEC FOXO1/PAX3 Dual Color Single Fusion Probe2 refs ZytoLight SPEC FOXO1/PAX3 TriCheck Probe ZytoLight SPEC FOXO1/PAX7 Dual Color Single Fusion Probe2 refs ZytoLight SPEC FUS Dual Color Break Apart Probe ZytoLight SPEC GATA2/MECOM Dual Color Dual Fusion Probe ZytoLight SPEC IGH Dual Color Break Apart Probe2 refs ZytoLight SPEC IGK Dual Color Break Apart Probe ZytoLight SPEC IGL Dual Color Break Apart Probe ZytoLight SPEC IKZF1/CEN 7 Dual Color Probe98/79 ZytoLight SPEC IRF4,DUSP22 Dual Color Break Apart Probe2 refs ZytoLight SPEC JAK2 Dual Color Break Apart Probe ZytoLight SPEC JAZF1 Dual Color Break Apart Probe ZytoLight SPEC KMT2A Dual Color Break Apart Probe2 refs ZytoLight SPEC KRAS/CEN 12 Dual Color Probe ZytoLight SPEC MAF/IGH Dual Color Dual Fusion Probe98/79 ZytoLight SPEC MAFB/IGH Dual Color Dual Fusion Probe98/79 ZytoLight SPEC MALT1 Dual Color Break Apart Probe2 refs ZytoLight SPEC MALT1/IGH Dual Color Dual Fusion Probe ZytoLight SPEC MAML2 Dual Color Break Apart Probe2 refs ZytoLight SPEC MCL1/1p12 Dual Color Probe ZytoLight SPEC MDM2/CEN 12 Dual Color Probe2 refs ZytoLight SPEC MDM4/1p12 Dual Color Probe ZytoLight SPEC MET/CEN 7 Dual Color Probe2 refs ZytoLight SPEC MYB Dual Color Break Apart Probe2 refs ZytoLight SPEC MYB/CEN 6 Dual Color Probe ZytoLight SPEC MYC Dual Color Break Apart Probe2 refs ZytoLight SPEC MYC/CEN 8 Dual Color Probe2 refs ZytoLight SPEC MYC/IGH Dual Color Dual Fusion Probe2 refs ZytoLight SPEC MYCN/2q11 Dual Color Probe2 refs ZytoLight SPEC NECTIN4/1p12 Dual Color Probe2 refs ZytoLight SPEC NR4A3 Dual Color Break Apart Probe ZytoLight SPEC NRG1 Dual Color Break Apart Probe ZytoLight SPEC NRG1/CD74 TriCheck Probe ZytoLight SPEC NTRK1 Dual Color Break Apart Probe2 refs ZytoLight SPEC NTRK2 Dual Color Break Apart Probe2 refs ZytoLight SPEC NTRK3 Dual Color Break Apart Probe2 refs ZytoLight SPEC NUP214 Dual Color Break Apart Probe98/79 ZytoLight SPEC NUP98 Dual Color Break Apart Probe ZytoLight SPEC NUTM1 Dual Color Break Apart Probe ZytoLight SPEC PAX5 Dual Color Break Apart Probe98/79 ZytoLight SPEC PDGFB Dual Color Break Apart Probe2 refs ZytoLight SPEC PDGFRA/FIP1L1 TriCheck Probe ZytoLight SPEC PDGFRB Dual Color Break Apart Probe ZytoLight SPEC PHF1 Dual Color Break Apart Probe ZytoLight SPEC PIK3CA/CEN 3 Dual Color Probe ZytoLight SPEC PML/RARA Dual Color Dual Fusion Probe2 refs98/79 ZytoLight SPEC Prader-Willi Dual Color Probe98/79 ZytoLight SPEC PTEN/CEN 10 Dual Color Probe2 refs ZytoLight SPEC PTPRT/20q11 Dual Color Probe ZytoLight SPEC RB1/13q34 Dual Color Probe2 refs98/79 ZytoLight SPEC RET Dual Color Break Apart Probe2 refs ZytoLight SPEC ROS1 Dual Color Break Apart Probe2 refs ZytoLight SPEC ROS1/CEN 6 Dual Color Probe2 refs ZytoLight SPEC RREB1/MYB/CEN 6 Triple Color Probe2 refs ZytoLight SPEC RUNX1/RUNX1T1 Dual Color Dual Fusion Probe2 refs98/79 ZytoLight SPEC SMARCB1/22q12 Dual Color Probe ZytoLight SPEC SS18 Dual Color Break Apart Probe2 refs ZytoLight SPEC SS18/SSX1 TriCheck Probe98/79 ZytoLight SPEC TCF3/PBX1 Dual Color Dual Fusion Probe98/79 ZytoLight SPEC TERT Dual Color Break Apart Probe ZytoLight SPEC TERT/5q31 Dual Color Probe2 refs ZytoLight SPEC TFE3 Dual Color Break Apart Probe2 refs ZytoLight SPEC TP53/17q22 Dual Color Probe ZytoLight SPEC TP53/ATM Dual Color Probe2 refs ZytoLight SPEC TP53/CEN 17 Dual Color Probe2 refs ZytoLight SPEC TP63/TBL1XR1 TriCheck Probe98/79 ZytoLight SPEC USP6 Dual Color Break Apart Probe2 refs ZytoLight SPEC VHL/1p12/CEN 7/17 Quadruple Color Probe2 refs ZytoLight SPEC VHL/CEN 3 Dual Color Probe ZytoLight SPEC Williams-Beuren Dual Color Probe98/79 ZytoLight SPEC WT1 Dual Color Break Apart Probe98/79 ZytoLight SPEC WWTR1 Dual Color Break Apart Probe98/79 ZytoLight SPEC YWHAE Dual Color Break Apart Probe ZytoLight SPEC ZNF384 Dual Color Break Apart Probe98/79 ZytoMation ALK Dual Color Break Apart FISH Probe98/79 ZytoMation BCL2 Dual Color Break Apart FISH Probe ZytoMation BCL6 Dual Color Break Apart FISH Probe98/79 ZytoMation ERBB2/CEN 17 Dual Color FISH Probe ZytoMation IGH Dual Color Break Apart FISH Probe98/79 ZytoMation MET/CEN 7 Dual Color FISH Probe98/79 ZytoMation MYC Dual Color Break Apart FISH Probe98/79 ZytoMation RET Dual Color Break Apart FISH Probe98/79 ZytoMation ROS1 Dual Color Break Apart FISH Probe	C IVDR, 98/79	EUDAMED record Report an error
IVD general use consumables devices - other accessories	W0580	100x Wash Buffer 10x MgCl2 10x PBS 20x Wash Buffer TBS 25x Wash Buffer A 47 others 5x FlexISH Wash Buffer2 refs AEC Solution Anti-Biotin/DIG-Mix Anti-DIG/DNP-Mix3 refs Anti-Mouse-HRP-Polymer AP-Red Solution A2 refs AP-Red Solution B2 refs Blocking Solution BS-0001-4 Blue Spot Solution Cytology Pepsin Solution ES-0002-163 refs Cytology Stringency Wash Buffer SSC Cytology Wash Buffer SSC DAB Solution A DAB Solution B DAB Solution Set DAPI/DuraTect-Solution3 refs DAPI/DuraTect-Solution (ultra) Detection Solution AB-0016-5 FlexISH-Tissue Implementation Kit2 refs Formaldehyde Dilution Buffer Set Heat Pretreatment Solution Citric3 refs Heat Pretreatment Solution EDTA2 refs HRP-Green Solution A2 refs HRP-Green Solution B2 refs HRP/AP-Polymer-Mix3 refs Hybridization Solution HY-0001-1 Mayer's Hematoxylin Solution Mounting Solution (alcoholic)3 refs Mounting Solution (aqueous) MT-0005-4 Mouse-anti-DIG NBT/BCIP Solution Nuclear Blue Solution2 refs Nuclear Green Solution PBS/Tween Pepsin Solution ES-0001-13 refs Permanent Red Solution A SB-0008a-0.25 Permanent Red Solution B SB-0008b-15 VisionArray Detection Kit Wash Buffer SSC2 refs ZyBlack Quenching Solution ZytoDot 2C CISH Implementation Kit2 refs ZytoDot AP-Red Solution Set ZytoDot CISH Implementation Kit ZytoDot HRP-Green Solution Set ZytoFast PLUS CISH Implementation Kit HRP-DAB ZytoLight FISH-Cytology Implementation Kit ZytoLight FISH-Tissue Implementation Kit2 refs	A IVDR	EUDAMED record Report an error
Histology / cytology reagents - other	W01030799	AEC Chromogen2 refs AEC Single Solution2 refs AEC Substrate Buffer2 refs AEC Substrate Kit2 refs Antibody Diluent2 refs 45 others Aura Chromo DAB 1 Aura Chromo RED 1 Aura Counterstain 1 Aura Detect Boost AP Aura Detect Boost HRP Aura Detect Fast HRP Aura Dewax 1 Aura Dewax 2 Aura Enzyme 1 Aura Pretreat 12 refs Aura Pretreat 2 Aura Pretreat 32 refs Aura Wash 12 refs Blocking Solution ZUC007-0063 refs DAB Chromogen2 refs DAB High Contrast Kit2 refs DAB Substrate Buffer2 refs DAB Substrate Buffer (High Contrast)2 refs DAB Substrate Kit2 refs Nova Aura FFPE FISH Kit Permanent AP-Red Buffer2 refs Permanent AP-Red Chromogen2 refs Permanent AP-Red Kit2 refs Peroxide Block ZUC019-008 PostBlock Reagent6 refs ZytoChem Plus (AP) Polymer anti-Mouse2 refs ZytoChem Plus (AP) Polymer anti-Rabbit3 refs ZytoChem Plus (AP) Polymer Kit3 refs ZytoChem Plus (HRP) Broad Spectrum (AEC) Kit ZytoChem Plus (HRP) Broad Spectrum (DAB) Kit ZytoChem Plus (HRP) Broad Spectrum Kit4 refs ZytoChem Plus (HRP) One-Step Polymer anti-Mouse/Rabbit2 refs ZytoChem Plus (HRP) Polymer anti-Mouse2 refs ZytoChem Plus (HRP) Polymer anti-Rabbit3 refs ZytoChem Plus (HRP) Polymer Kit3 refs ZytoChem Plus biotinylated secondary antibody, broad spectrum3 refs ZytoChem Plus Streptavidin-HRP Conjugate3 refs Zytomed Systems HIER Citrate Buffer pH 6.0 (10x)2 refs Zytomed Systems HIER TRIS-EDTA Buffer pH 8.0 (10x) Zytomed Systems HIER TRIS-EDTA Buffer pH 9.0 (10x)2 refs Zytomed Systems OmniPrep Solution pH 6.0 (10x) Zytomed Systems OmniPrep Solution pH 9.0 (10x) Zytomed Systems TRIS Wash Buffer (20x) Zytomed Systems TRIS Wash Buffer B (20x)2 refs Zytomed Systems Wash Buffer (20x)2 refs	A IVDR	EUDAMED record Report an error
Various general purpose IVD instruments - software accessories	W02079082	VisionArray MultiScan Software VisionArray SingleScan Software	A IVDR	EUDAMED record Report an error
Primary antisera for immunohistology	W01030709	Rabbit anti-Helicobacter pylori [polyclonal]3 refs	C IVDR	EUDAMED record Report an error

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