BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Permanent Red Solution A

    Reg #: 3005704042 · FEI: 3005704042 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    267
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ZYTOVISION GMBH
    Registration Number
    3005704042
    FEI Number
    3005704042
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Fischkai 1
    City
    Bremerhaven Bremen
    Country
    DE

    Owner / Operator

    Firm Name
    ZytoVision GmbH
    Operator Number
    10045618
    Address
    Fischkai 1
    City
    Bremerhaven
    State
    Bremen
    Postal Code
    27572
    Country
    DE
    Correspondent
    Julian Schmidt

    US Agent

    Business Name
    Qserve Group US Inc
    Contact Name
    Mindy McCann
    Address
    350 S Main Street, Suite 309
    City
    Doylestown
    State
    PA
    ZIP
    18901
    Country
    US
    Email
    [email protected]
    Phone
    424 2718169

    Products

    Device Name Product Code
    General Purpose Reagent PPM

    Proprietary Names

    Permanent Red Solution A ZytoLight SPEC MDM2/CEN 12 Dual Color Probe ZytoLight SPEC EWSR1 Dual Color Break Apart Probe ZytoLight SPEC ETV6 Dual Color Break Apart Probe ZytoLight SPEC NRG1/CD74 TriCheck Probe ZytoLight SPEC PDGFRA/FIP1L1 TriCheck Probe ZytoLight SPEC MAFB/IGH Dual Color Dual Fusion Probe ZytoMation IGH Dual Color Break Apart FISH Probe FlexISH-Tissue Implementation Kit ZytoDot 2C SPEC MET/CEN 7 Probe VisionArray MYCO PreCise Master Mix 2 ZytoLight SPEC CCND1/IGH Dual Color Dual Fusion Probe ZytoLight SPEC RREB1/MYB/CEN 6 Triple Color Probe ZytoLight SPEC FGFR3/IGH Dual Color Dual Fusion Probe ZytoLight SPEC ATM/CEN 11 Dual Color Probe Pepsin Solution Mounting Solution (aqueous) ZytoDot 2C SPEC ROS1 Break Apart Probe ZytoFast human lg-kappa/lg-lambda Probe ZytoLight SPEC 1p36/1q25 Dual Color Probe ZytoLight SPEC ETV6/RUNX1 Dual Color Dual Fusion Probe ZytoLight SPEC DiGeorge/Phelan McDermid Dual Color Probe DAPI/DuraTect-Solution ZytoLight SPEC MAML2 Dual Color Break Apart Probe ZytoLight SPEC SS18 Dual Color Break Apart Probe ZytoLight SPEC COL1A1/PDGFB Dual Color Dual Fusion Probe ZytoLight SPEC BCL6 Dual Color Break Apart Probe ZytoLight SPEC VEGFA/CEN 6 Dual Color Probe ZytoLight SPEC IRF4,DUSP22 Dual Color Break Apart Probe ZytoLight Glioma 1p/19q Probe Set AP-Red Solution B ZytoDot SPEC ERBB2 Probe ZytoLight SPEC MET/CEN 7 Dual Color Probe ZytoLight SPEC TFE3 Dual Color Break Apart Probe ZytoLight SPEC FOXO1/PAX3 TriCheck Probe ZytoLight SPEC NUP214 Dual Color Break Apart Probe Nuclear Green Solution ZytoDot 2C SPEC SS18 Break Apart Probe ZytoLight SPEC CDK4/CEN 12 Dual Color Probe ZytoLight SPEC PDGFB Dual Color Break Apart Probe ZytoLight SPEC TP53/17q22 Dual Color Probe ZytoLight SPEC ZNF384 Dual Color Break Apart Probe DAB Solution Set ZytoDot 2C SPEC EGFR/CEN 7 Probe ZytoDot 2C SPEC CDKN2A/CEN 9 Probe ZytoLight CEN X/Yq12 Dual Color Probe ZytoLight SPEC KRAS/CEN 12 Dual Color Probe ZytoLight SPEC FOXO1 Dual Color Break Apart Probe ZytoLight SPEC IGK Dual Color Break Apart Probe Heat Pretreatment Solution Citric ZytoDot 2C SPEC ALK Break Apart Probe ZytoLight SPEC FGFR2/CEN 10 Dual Color Probe ZytoLight SPEC RET Dual Color Break Apart Probe ZytoLight SPEC CRLF2 Dual Color Break Apart Probe ZytoLight SPEC D13S319/13q34 Dual Color Probe FlexISH IGK/IGL DistinguISH Probe ZytoLight FISH-Tissue Implementation Kit ZytoDot 2C SPEC ERBB2/CEN 17 Probe ZytoDot 2C SPEC MYC Break Apart Probe ZytoLight SPEC BCL2/IGH Dual Color Dual Fusion Probe ZytoLight SPEC ERG Dual Color Break Apart Probe ZytoLight SPEC MAF/IGH Dual Color Dual Fusion Probe ZytoLight SPEC GATA2/MECOM Dual Color Dual Fusion Probe 100x Wash Buffer ZytoDot 2C SPEC ERBB2/CEN 17 Probe Kit ZytoLight SPEC RUNX1/RUNX1T1 Dual Color Dual Fusion Probe ZytoLight SPEC JAZF1 Dual Color Break Apart Probe ZytoLight SPEC BRAF/CEN 7 Dual Color Probe ZytoLight SPEC CSF1R/D5S23,D5S721 Dual Color Probe ZytoLight SPEC CIC Dual Color Break Apart Probe 25x Wash Buffer A Anti-Biotin/DIG-Mix ZytoLight CEN 8 Probe ZytoLight SPEC FGFR1/CEN 8 Dual Color Probe ZytoLight SPEC ERBB2/TOP2A/CEN 17 Triple Color Probe ZytoLight SPEC MCL1/1p12 Dual Color Probe ZytoLight SPEC BCL2 Dual Color Break Apart Probe ZytoLight SPEC CBFB Dual Color Break Apart Probe ZytoMation ALK Dual Color Break Apart FISH Probe Hybridization Solution Mounting Solution (alcoholic) Anti-DIG/DNP-Mix VisionArray Myco Chip 2 ZytoLight SPEC CCND1/CEN 11 Dual Color Probe ZytoLight SPEC MYC/CEN 8 Dual Color Probe ZytoLight SPEC FGFR3 Dual Color Break Apart Probe ZytoLight SPEC NTRK3 Dual Color Break Apart Probe FlexISH NTRK1/NTRK3 DistinguISH Probe 5x FlexISH Wash Buffer ZytoDot 2C SPEC 19q13/19p13 Probe ZytoLight SPEC ERBB2/CEN 17 Dual Color Probe ZytoLight SPEC DDIT3 Dual Color Break Apart Probe ZytoLight SPEC ALK/EML4 TriCheck Probe ZytoLight SPEC MALT1 Dual Color Break Apart Probe ZytoLight SPEC EGR1/D5S23,D5S721 Dual Color Probe ZytoLight SPEC TERT Dual Color Break Apart Probe ZytoFast PLUS CISH Implementation Kit HRP-DAB Blocking Solution ZytoDot 2C SPEC BCL2 Break Apart Probe ZytoLight SPEC FOXO1/PAX7 Dual Color Single Fusion Probe ZytoLight SPEC WT1 Dual Color Break Apart Probe ZytoLight CLL Probe Set ZytoMation BCL2 Dual Color Break Apart FISH Probe ZytoDot 2C CISH Implementation Kit ZyBlack Quenching Solution ZytoDot 2C SPEC DDIT3 Break Apart Probe ZytoLight CEN X/Y Dual Color Probe ZytoLight SPEC ABL1 Dual Color Break Apart Probe ZytoLight SPEC CKS1B/CDKN2C Dual Color Probe ZytoLight FISH-Cytology Implementation Kit ZytoDot 2C SPEC MDM2/CEN 12 Probe ZytoLight SPEC COL1A1 Dual Color Break Apart Probe ZytoLight SPEC ABL2 Dual Color Break Apart Probe ZytoLight Aneuploidy Panel 18/X/Y and 13/21 ZytoLight SPEC JAK2 Dual Color Break Apart Probe DAB Solution A ZytoDot 2C SPEC USP6 Break Apart Probe ZytoFast HPV High-Risk (HR) Types Probe ZytoLight CEN 12 Probe ZytoLight SPEC NR4A3 Dual Color Break Apart Probe ZytoLight SPEC NTRK1 Dual Color Break Apart Probe ZytoLight SPEC CSF1R Dual Color Break Apart Probe FlexISH MYC/IGH TriCheck Probe ZytoLight SPEC BCOR Dual Color Break Apart Probe Formaldehyde Dilution Buffer Set ZytoDot 2C SPEC FGFR2/CEN 10 Probe VisionArray HPV PreCise Master Mix ZytoLight SPEC ALK Dual Color Break Apart Probe ZytoLight SPEC USP6 Dual Color Break Apart Probe ZytoLight SPEC MYB/CEN 6 Dual Color Probe ZytoLight SPEC ATM/CEN 12 Dual Color Probe 20x Wash Buffer TBS ZytoDot 2C SPEC CDK4/CEN 12 Probe ZytoFast human lg-kappa/lg-lambda CISH Kit ZytoLight SPEC MYCN/2q11 Dual Color Probe ZytoLight SPEC FUS Dual Color Break Apart Probe ZytoLight SPEC TP53/CEN 17 Dual Color Probe ZytoMation ROS1 Dual Color Break Apart FISH Probe ZytoDot CISH Implementation Kit Wash Buffer SSC ZytoDot 2C SPEC 1p36/1q25 Probe ZytoDot 2C SPEC IGH Break Apart Probe ZytoLight SPEC FOXO1/PAX3 Dual Color Single Fusion Probe ZytoLight SPEC PIK3CA/CEN 3 Dual Color Probe ZytoLight SPEC DiGeorge Triple Color Probe AEC Solution Cytology Stringency Wash Buffer SSC ZytoFast HPV type 16/18 Probe ZytoLight CEN 17/SPEC ERBB2 Dual Color Probe ZytoLight SPEC D13S319/13q34/CEN 12 Triple Color Probe ZytoLight SPEC SMARCB1/22q12 Dual Color Probe ZytoLight SPEC Williams-Beuren Dual Color Probe ZytoLight SPEC Angelman Dual Color Probe Blue Spot Solution ZytoDot SPEC MDM2 Probe ZytoLight SPEC BCR/ABL1 Dual Color Dual Fusion Probe ZytoLight SPEC ERBB2/D17S122 Dual Color Probe ZytoLight SPEC CREBBP Dual Color Break Apart Probe FlexISH BCL2/BCL6 DistinguISH Probe DAPI/DuraTect-Solution (ultra) ZytoDot 2C SPEC EWSR1 Break Apart Probe ZytoLight SPEC VHL/1p12/CEN 7/17 Quadruple Color Probe ZytoLight SPEC CCND1 Break Apart/2q11/CEN 6 Quadruple Color Probe ZytoLight SPEC PDGFRB Dual Color Break Apart Probe ZytoLight SPEC WWTR1 Dual Color Break Apart Probe ZytoLight SPEC C19MC/19p13 Dual Color Probe HRP/AP-Polymer-Mix VisionArray MultiScan Software ZytoFast human lg-kappa Probe ZytoLight SPEC FGFR3/4p11 Dual Color Probe ZytoLight SPEC MYC/IGH Dual Color Dual Fusion Probe ZytoLight SPEC EWSR1/FLI1 TriCheck Probe ZytoLight SPEC PHF1 Dual Color Break Apart Probe Heat Pretreatment Solution EDTA Cytology Wash Buffer SSC ZytoFast HPV type 31/33 Probe ZytoLight SPEC PTEN/CEN 10 Dual Color Probe ZytoLight SPEC ALK/2q11 Dual Color Probe ZytoLight SPEC CD274,PDCD1LG2/CEN 9 Dual Color Probe ZytoLight SPEC IKZF1/CEN 7 Dual Color Probe ZytoLight SPEC TP63/TBL1XR1 TriCheck Probe AP-Red Solution A VisionArray SingleScan Software ZytoLight SPEC VHL/CEN 3 Dual Color Probe ZytoLight SPEC CCND1 Dual Color Break Apart Probe ZytoLight SPEC SS18/SSX1 TriCheck Probe ZytoLight SPEC 11q gain/loss Triple Color Probe NBT/BCIP Solution Cytology Pepsin Solution ZytoFast HPV type 6/11 Probe ZytoLight SPEC 19q13/19p13 Dual Color Probe ZytoLight SPEC TP53/ATM Dual Color Probe ZytoLight SPEC PAX5 Dual Color Break Apart Probe ZytoLight SPEC Prader-Willi Dual Color Probe 10x MgCl2 ZytoFast human lg-kappa/lg-lambda Permanent CISH Kit ZytoLight SPEC MDM4/1p12 Dual Color Probe ZytoLight SPEC ROS1/CEN 6 Dual Color Probe ZytoLight SPEC 21/CEN X/Yq12 Triple Color Probe ZytoLight SPEC PTPRT/20q11 Dual Color Probe ZytoLight Bladder Cancer Quadruple Color Probe ZytoMation MET/CEN 7 Dual Color FISH Probe 10x PBS ZytoFast EBV Probe ZytoLight SPEC CDKN2A/CEN 3/7/17 Quadruple Color Probe ZytoLight Aneuploidy Panel X/Y and 13/18/21 ZytoLight SPEC 18/CEN X/Y Triple Color Probe ZytoLight SPEC NRG1 Dual Color Break Apart Probe ZytoLight SPEC CUX1/EZH2/CEN 7 Triple Color Probe ZytoLight SPEC RB1/13q34 Dual Color Probe Nuclear Blue Solution Permanent Red Solution B ZytoLight CEN 11 Probe ZytoLight SPEC 13/CEN 18/SPEC 21 Triple Color Probe ZytoLight SPEC YWHAE Dual Color Break Apart Probe ZytoLight SPEC KMT2A Dual Color Break Apart Probe ZytoLight SPEC NUTM1 Dual Color Break Apart Probe ZytoMation RET Dual Color Break Apart FISH Probe ZytoDot AP-Red Solution Set Mouse-anti-DIG ZytoDot 2C SPEC BCL6 Break Apart Probe ZytoLight SPEC ERBB2/CEN 17 Dual Color Probe Kit ZytoLight SPEC MYB Dual Color Break Apart Probe ZytoLight SPEC 13/21 Dual Color Probe ZytoLight SPEC SPI1 Dual Color Break Apart Probe ZytoLight SPEC 4p11/Cen 10/17 Triple Color Probe PBS/Tween Mayer's Hematoxylin Solution HRP-Green Solution B ZytoDot 2C SPEC NTRK3 Break Apart Probe VisionArray HPV Chip 1 ZytoLight SPEC ESR1/CEN 6 Dual Color Probe ZytoLight SPEC TERT/5q31 Dual Color Probe ZytoLight SPEC FGFR2 Dual Color Break Apart Probe ZytoLight SPEC NTRK2 Dual Color Break Apart Probe ZytoMation BCL6 Dual Color Break Apart FISH Probe VisionArray Detection Kit ZytoDot SPEC MYCN Probe ZytoDot 2C SPEC RET Break Apart Probe ZytoLight SPEC PML/RARA Dual Color Dual Fusion Probe ZytoLight SPEC ERG/TMPRSS2 TriCheck Probe FlexISH RET/KIF5B TriCheck Probe ZytoLight SPEC IGL Dual Color Break Apart Probe Detection Solution HRP-Green Solution A ZytoDot SPEC ERBB2 Probe Kit ZytoLight SPEC IGH Dual Color Break Apart Probe ZytoLight SPEC BRAF Dual Color Break Apart Probe ZytoLight SPEC NUP98 Dual Color Break Apart Probe ZytoDot HRP-Green Solution Set Anti-Mouse-HRP-Polymer ZytoDot 2C Glioma 1p/19q Probe Set ZytoFast human lg-lambda Probe ZytoLight SPEC EGFR/CEN 7 Dual Color Probe ZytoLight SPEC ROS1 Dual Color Break Apart Probe FlexISH ERBB2/CEN 17 Dual Color Probe ZytoMation ERBB2/CEN 17 Dual Color FISH Probe ZytoLight SPEC TCF3/PBX1 Dual Color Dual Fusion Probe DAB Solution B ZytoDot 2C SPEC NTRK1 Break Apart Probe ZytoFast HPV Screening Probe ZytoLight SPEC CDKN2A/CEN 9 Dual Color Probe ZytoLight SPEC MYC Dual Color Break Apart Probe ZytoLight SPEC BIRC3/MALT1 Dual Color Dual Fusion Probe ZytoLight SPEC FGFR1 Dual Color Break Apart Probe FlexISH ALK/ROS1 DistinguISH Probe ZytoMation MYC Dual Color Break Apart FISH Probe

    Establishment Types

    Manufacture Medical Device