BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PathVysion HER-2 DNA Probe Kit II, 20 assay for Gastric Her 2

    Reg #: 3005248192 · FEI: 3005248192 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    90
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ABBOTT MOLECULAR, INC.
    Registration Number
    3005248192
    FEI Number
    3005248192
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1300 EAST TOUHY AVENUE
    City
    Des Plaines
    State
    IL
    ZIP
    60018
    Country
    US

    Owner / Operator

    Firm Name
    ABBOTT LABORATORIES
    Operator Number
    1415939
    Address
    100 ABBOTT PARK RD., D-03Q3, AP52-1
    City
    Abbott Park
    State
    IL
    Postal Code
    60064
    Country
    US

    Products

    Device Name Product Code
    Dna-Probe Kit, Human Chromosome OYU

    Proprietary Names

    PathVysion HER-2 DNA Probe Kit II, 20 assay for Gastric Her 2 MultiVysion PB Multi-Color Probe Set Vysis ZNF217 SpectrumGold FISH Probe Kit Vysis Cervical FISH Probe Kit Vysis ATM/CEP 11 FISH Probe Kit Vysis IGH/MYC/CEP 8 Tri-Color DF FISH Probe Kit Vysis PDGFRB Break Apart FISH Probe Kit Vysis PTEN /CEP 10 FISH Probe Kit Vysis LSI ATM (11q22.3) SpectrumOrange Probe Vysis BCL2 Break Apart FISH Probe Kit Vysis SS18 Break Apart FISH Probe Kit Vysis TP53/CEP 17 FISH Probe Kit Vysis TRA/D Break Apart FISH Probe Kit Vysis LSI BCR/ABL Dual Color, Singlel Fusion Translocation Probe Set Vysis LSI 21 SpectrumOrange Probe Vysis EWSR1 Break apart FISH Probe Kit Vysis LSI 13 (13q14) SpectrumGreen Vysis Prader-Willi/Angelman Region SNRPN/CEP 15/PML FISH Probe Kit Vysis LSI ETV6 (TEL)/RUNX1 (AML) ES Dual Color, Translocation Probe Set Vysis CCND1 Break Apart FISH Probe Kit Vysis LSI BCR/ABL ES Dual Color Translocation Probe Set Vysis LSI IGH/BCL2 Dual Color, Dual Fusion Translocation Probe Set Vysis 1p36/1q25 and 19q13/19p13 FISH Probe Kit Vysis 13q34 SpectrumGreen FISH Probe Kit Vysis BCR/ABL1/ASS1 Tri-Color DF FISH Probe Kit Vysis LSI MLL Dual Color, Break Apart Rearrangement Probe Vysis IGH/CCND1 XT DF FISH Probe Kit Vysis MALT1 Break Apart FISH Probe Kit Vysis MDM2/CEP 12 FISH Probe Kit Vysis RPN1/MECOM DF FISH Probe Kit Vysis D7S522/CEP 7 FISH Probe Kit PathVysion HER-2 DNA Probe Kit II, 100 assay for Gastric Her 2 Vysis D5S23, D5S721/CEP 9/CEP 15 FISH Probe Kit Vysis ETV6 Break Apart FISH Probe Kit Vysis TOP2A/CEP 17 Fish Probe Kit Vysis LSI D13S319 (13q14.3) SpectrumOrange Probe Vysis LSI RB1 (13q14) SpectrumOrange Probe Vysis LSI PMLRARA Dual Color, Dual Fusion Translocation Probe Set PathVysion HER-2 DNA Probe Kit II, 50 assay for Gastric Her 2 Vysis 9q34 SpectrumAqua FISH Probe Kit Vysis MYB SpectrumAqua FISH Probe Kit Vysis LSI D13S25 (13q14.3) Spectrum Orange Probe Vysis ToTelVysion Multi-color FISH Probe Kit Vysis LSI EGR1/D5S23, D5S721 Dual Color Probe Set Vysis MYC SpectrumOrange FISH Probe Kit Vysis BRAF SpectrumGold FISH Probe Kit Vysis IGH/MALT1 DF FISH Probe Kit Vysis BIRC3/MALT1 DF FISH Probe Kit Vysis MET SpectrumRed FISH Probe Kit Vysis D20S108 FISH Probe Kit Vysis TOP2A/HER-2/CEP 17 FISH Probe Kit Vysis D13S319/13q34 FISH Probe Kit UroVysion Bladder Cancer Kit (Kit with 20 / 100 tests) Vysis LSI TUPLE1 (HIRA) SpectrumOrange/LSI ARSA SpectrumGreen Probe Set Vysis DDIT3 Break Apart FISH Probe Kit Vysis Melanoma FISH Probe Kit Vysis RUNX1/RUNX1T1 DF FISH Probe Kit (Vysis LSI AML1/ETO Dual Color, Dual Fusion Translocation Probe) Vysis IGH/FGFR3 DF FISH Probe Kit Vysis Prader-Willi/Angelman Region D15S10/CEP 15/PML FISH Probe Kit Vysis Esophageal FISH Probe Kit Vysis RARA Break Apart FISH Probe Kit Vysis MultVysion PGT Multi-Color FISH Probe Kit Vysis LSI BCR/ABL Dual Color, Dual Fusion Translocation Probe Set, 20 Assays Vysis MYC Break Apart FISH Probe Kit Vysis FOXO1 Break Apart FISH Probe Kit Vysis ETV6/RUNX1 DF FISH Probe Kit Vysis EGFR/CEP 7 FISH Probe Kit Vysis ZNF217 SpectrumRed FISH Probe Kit BCR/ABL 9q34 Tricolor, Dual Fusion Translocation Probe Vysis LSI p53/LSI ATM and LSI D13S319/ LSI 13q34/CEP 12 Multi-Color Probe Sets Vysis D7S486/CEP 7 FISH Probe Kit Vysis LSI BCR/ABL Dual Color, Dual Fusion Translocation Probe Set, 50 Assays Vysis FUS Break Apart FISH Probe Kit Vysis 4q12 Tri-Color Rearrangement FISH Probe Kit Vysis CDKN2A /CEP 9 FISH Probe Kit (Vysis LSI p16 (9p21)/CEP 9 Dual Color Probe) Vysis LSI p53 (17p13.1) SpectrumOrange Probe Vysis ALK Break Apart FISH Probe Kit ProbeChek ALK Negative Control Slides ProbeChek ALK Positive Control Slides Vysis PML/RARA SF FISH Probe Kit ProbeChek Control Slides for UroVysion Bladder Cancer Kit Vysis CSF1R/D5S23, D5S721 FISH Probe Kit Vysis PIK3CA SpectrumGreen FISH Probe Kit Vysis SRY/CEP X FISH Probe Kit Vysis IGH/MAF DF FISH Probe Kit Vysis LSI IGH Dual Color, Break Apart Rearrangement Probe Vysis CCND1/CEP 11 FISH Probe Kit Vysis ZNF217 SpectrumOrange FISH Probe Kit Vysis AURKA SpectrumGold FISH Probe Kit Vysis Williams Region Probe ELN/D7S486, D7S522 FISH Probe Kit Vysis CBFB Break Apart FISH Probe Kit Vysis IGH/CCND1 DF FISH Probe Kit

    Establishment Types

    Manufacture Device in the United States for Export Only