ReagentsHaematology / haemostasis / immunohaematology / histology / cytologyHistology/cytology reagents

DNA in situ hybridisation reagents

EMDN code W01030703

10 manufacturers, 418 models including 418 on the market, 8 countries

On the market in Manufacturer country

Manufacturers registered in Europe (EUDAMED) 10

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

Manufacturer	Country	Registered models	Class	Contact
ZytoVision FDA	Germany	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	Website info@zytovision.com EUDAMED record Report an error
Oacp	Ireland	Bladder Cancer cells chromosome and gene anomaly detection probe98/79 CL-004 fp-001 FP-00298/79 FP-00398/79 148 others FP-004 (FP-044)98/79 FP-00598/79 FP-00698/79 FP-00798/79 FP-0115 refs98/79 FP-011-698/79 FP-01298/79 FP-01398/79 FP-0143 refs98/79 FP-01598/79 FP-01698/79 FP-01898/79 FP-01998/79 FP-02098/79 FP-02198/79 FP-02298/79 FP-02398/79 FP-02498/79 FP-02598/79 FP-02698/79 FP-02798/79 FP-02898/79 FP-02998/79 FP-03098/79 FP-03198/79 FP-03298/79 FP-03398/79 FP-03498/79 FP-03598/79 FP-03698/79 FP-03798/79 FP-03898/79 FP-03998/79 FP-04098/79 FP-04198/79 FP-04298/79 FP-04398/79 FP-04598/79 FP-04698/79 FP-04998/79 FP-05198/79 FP-05298/79 FP-05398/79 FP-05498/79 FP-05598/79 FP-05998/79 FP-06298/79 FP-07498/79 FP-07598/79 FP-07698/79 FP-07798/79 FP-07998/79 FP-08098/79 FP-08198/79 FP-08298/79 FP-08398/79 FP-08598/79 FP-09198/79 FP-09298/79 FP-09398/79 FP-09498/79 FP-10098/79 FP-10198/79 FP-10898/79 FP-11298/79 FP-11398/79 FP-11798/79 FP-11898/79 FP-12398/79 FP-12598/79 FP-12898/79 FP-13798/79 FP-14198/79 FP-14298/79 FP-14398/79 FP-14898/79 FP-14998/79 FP-15098/79 FP-15198/79 FP-15498/79 FP-15898/79 FP-15998/79 FP-16098/79 FP-16898/79 FP-17498/79 FP-18198/79 FP-18398/79 FP-18598/79 FP-18698/79 FP-19198/79 FP-19398/79 FP-19798/79 FP-19898/79 FP-20698/79 FP-20898/79 FP-21698/79 FP-22698/79 FP-22798/79 FP-230-598/79 FP-23298/79 FP-232-198/79 FP-232-298/79 FP-232-398/79 FP-233-198/79 FP-233-298/79 FP-233-398/79 FP-233-498/79 FP-234-198/79 FP-234-298/79 FP-234-398/79 FP-24098/79 FP-242-398/79 FP-242-498/79 FP-243-198/79 FP-243-298/79 FP-243-398/79 FP-245-398/79 FP-245-498/79 FP-25198/79 FP-26098/79 FP-26298/79 FP-26598/79 FP-26698/79 FP-26798/79 FP-29798/79 FP-30498/79 FP-31498/79 FP-315-198/79 FP-315-298/79 FP-34098/79 FP-34198/79 FP-342-298/79 FP-342-398/79 FP-34498/79 FP-34998/79 FP-37098/79 FP-38698/79 FP-39898/79 FP-40898/79 FP-41098/79 FP-41298/79 In situ Hybridization staining solution CL-004 Rapid ISH Integra Plus Rapid-ISH Hemato Rapid-ISH Integra Rapid-ISH Integra Recovery Smart-ISH Solve TOP2A gene amplification probe detection kit98/79	A IVDR, 98/79	Website EUDAMED record Report an error
Vitro FDA	Spain	master diagnóstica MAD-001VS2 refs master diagnóstica MAD-002VS master diagnóstica MAD-003VS2 refs master diagnóstica MAD-004VS2 refs master diagnóstica MAD-005VS2 refs 15 others master diagnóstica MAD-006VS2 refs master diagnóstica MAD-007VS2 refs master diagnóstica MAD-008VS2 refs master diagnóstica MAD-009VS2 refs master diagnóstica MAD-010VS2 refs master diagnóstica MAD-011VS2 refs master diagnóstica MAD-013VS2 refs master diagnóstica MAD-014VS2 refs master diagnóstica MAD-015VS2 refs master diagnóstica MAD-016VS2 refs master diagnóstica MAD-017VS2 refs master diagnóstica MAD-018VS2 refs master diagnóstica MAD-019VS2 refs master diagnóstica MAD-024VS2 refs master diagnóstica MAD-025VS2 refs	C IVDR	Website regulatory@vitro.bio EUDAMED record Report an error
Leicabiosystems FDA EU representative : AR Experts B.V. (Netherlands)	United Kingdom (ex Northern Ireland)	DNA Negative Control 6.25 mL PB073198/79 DNA Positive Control Probe 6.25 mL PB068298/79 EBER Probe 5.5 mL PB058998/79 FISH Digestion Kit KBI-60006 FISH Reagent Kit KBI-60005 8 others HPV Probe (subtypes 16, 18, 31, 33, 51) 6.25 mL PB082998/79 HPV Probe (subtypes 6, 11) 6.25 mL PB078098/79 Kappa Probe 5.5 mL PB064598/79 Lambda Probe 5.5 mL PB066998/79 RNA Negative Control Probe PB080998/79 RNA Positive Control probe 5.5 mL PB078598/79 Tissue Digestion Kit I KBI-60007 Tissue Digestion Kit II KBI-60004	A IVDR, 98/79	Website EUDAMED record Report an error
Agilent FDA EU representative : Agilent Technologies Denmark ApS (Denmark)	Singapore, United States	Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A K589911-21 Histology FISH Accessory Kit K579911-2 ISH Ethanol Solution 96% (Dako Omnis) GM30011-2 ISH Pepsin (Dako Omnis) GM30211-2 ISH Pre-Treatment Solution (20x) (Dako Omnis) GM30111-2 2 others ISH Stringent Washing Buffer (20x) (Dako Omnis) GM30311-2 PNA ISH Detection Kit K520111-2	A IVDR	Website info.dk@agilent.com EUDAMED record Report an error
Dartmon FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	ISH EBER Probe DMRD057798/79 ISH Kappa Probe DMRD057998/79 ISH Lambda Probe DMRD058098/79	– 98/79	Website EUDAMED record Report an error
Kreatech Biotechnology	Netherlands	BCL2/IGH t(14;18) Fusion KBI-1060698/79 DEK / NUP214 t(6;9) Fusion KBI-1030698/79 PDGFRB (5q32) Break KBI-1000498/79	– 98/79	Website QA.Amsterdam@leicabiosystems.com EUDAMED record Report an error
Advanced Cell Diagnostics FDA EU representative : QbD RepS BV (Belgium)	United States	RNAscope™ ISH Probe High Risk HPV98/79 RNAscope™ ISH Probe UBC (Positive Control)98/79	– 98/79	EUDAMED record Report an error
Yzymedical EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	IGH Dual Color Break Apart Probe (fluorescence in situ hybridization )98/79 ROS1 Dual Color Break Apart Probe (fluorescence in situ hybridization )98/79	– 98/79	EUDAMED record Report an error
Cytocell FDA EU representative : Sysmex Europe SE (Germany)	United Kingdom (ex Northern Ireland)	DAPI Antifade ES2 refs	A IVDR	Website contact@ogt.com EUDAMED record Report an error

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