Vysis CEP 8 (D8Z2) (? satellite) SpectrumAqua Probe

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	Device Class	Medical Specialty	Exempt	Created
Reagents, Specific, Analyte	MVU	Class 1	Pathology	No	2000-01-28

Proprietary Names

Vysis CEP 8 (D8Z2) (? satellite) SpectrumAqua Probe Vysis TelVysion 3p SpectrumGreen Probe Vysis TelVysion 9p SpectrumGreen Probe Vysis LSI MYC (8q24.12-q24.13) SpectrumOrange Probe Vysis LSI RUNX1/RUNX1T1 Dual Color Dual Fusion Probes Vysis TelVysion 10q SpectrumOrange Probe Vysis CEP 6 (D6Z1) (? satellite) SpectrumAqua Probe Vysis TelVysion 3q SpectrumOrange Probe Vysis Williams Region LSI ELN SpectrumOrange/D7S486, D7S522 SpectrumGreen Probes Vysis BRAF SpectrumGold Probe Vysis LSI SRY SpectrumOrange Probe Vysis TelVysion 19q SpectrumOrange Probe Vysis CEP 9 (? satellite) SpectrumAqua Probe Vysis CEP 7 (D7Z1) (? satellite) SpectrumAqua Probe Vysis CEP X (DXZ1) (? satellite) SpectrumAqua Vysis CEP 20 (D20Z1) SpectrumOrange Probe Vysis TelVysion 2p SpectrumGreen Probe Vysis TelVysion 22q SpectrumOrange Probe Vysis TelVysion Xq/Yq SpectrumOrange Probe Vysis LSI p16 (9p21) SpectrumRed Probe Vysis CEP 4 (? satellite) SpectrumOrange Probe Vysis CEP 9 (? satellite) SpectrumGreen Probe Vysis LSI D13S319 (13q14.3) SpectrumOrange Probe Vysis CEP 9 (? satellite) SpectrumOrange Probe Vysis LSI SNRPN SpectrumOrange/CEP 15 SpectrumAqua/PML SpectrumGreen Probes, 10 ?L Vysis LSI TERC (3q26) SpectrumGold Probe Vysis LSI BCR/ABL1/ASS1 Tri-color Dual Fusion Probes (50 ?L) Vysis LSI D15S10 SO/ CEP 15 SA/PML SGn Probes Vysis TelVysion 2q SpectrumOrange Probe Vysis TelVysion 16q SpectrumOrange Probe Vysis CEP 17 (D17Z1) (? satellite) SpectrumOrange Vysis LSI TUPLE1 SpectrumOrange/TelVysion 22q SpectrumGreen Probes Vysis TelVysion 17q SpectrumOrange Probe Vysis Kallmann Region LSI KAL SpectrumOrange/CEP X SpectrumGreen Probes Vysis CEP 18 (D18Z1) (? satellite) SpectrumOrange Probe Vysis LSI CBFB Dual Color Break Apart Rearrangement Probe Vysis LSI Xq13.2 (XIST) SO Probe Vysis TelVysion 1q SpectrumOrange Probe Vysis LSI FOXO1 (13q14) Dual Color Break Apart Rearrangement Probe Vysis LSI BCR/ABL Dual Color Single Fusion Probes Vysis TelVysion 12p SpectrumGreen Probe Vysis LSI IGH Dual Color, Break Apart Rearrangement Probe Vysis LSI CSF1R SpectrumOrange/D5S23,D5S721 SpectrumGreen Probes Vysis LSI IGH/MYC/CEP 8 Tri-color Dual Fusion Probes Vysis CEP X (DXZ1) (? satellite) SpectrumOrange Probe Vysis LSI TP53 Spectrum Orange / CEP 17 Spectrum Green Probe Vysis LSI 21 SpectrumOrange Probe Vysis CEP 11 (D11Z1) (? satellite) SpectrumOrange Probe Vysis TelVysion 11q SpectrumOrange Probe Vysis CEP 18 (D18Z1) (? satellite) SpectrumAqua Probe Vysis TelVysion 6q SpectrumOrangeProbe Vysis LSI RARA Dual Color, Break Apart Rearrangement Probe Vysis D7S522/CEP 7 FISH Probe Kit Vysis TelVysion 5p SpectrumGreen Probe Vysis LSI TRA/D Dual Color Break Apart Rearrangement Probe Vysis LSI 22 (BCR) SpectrumGreen Probe Vysis LSI KRAS SpectrumGold Probe Vysis LSI LPL SpectrumOrange Probe Vysis LSI IGH/BCL2 Dual Color Dual Fusion Probes Vysis Prader-Willi/Angelman Region LSI GABRB3 SpectrumOrange/CEP 15 SpectrumGreen Probes Vysis LSI 13 (RB1) 13q14 SpectrumOrange Probe Vysis TelVysion 17p SpectrumGreen Probe Vysis LSI RPN1 SpectrumGreen Probe Vysis CEP 6 (D6Z1) (? satellite) SpectrumGreen Vysis CEP 10 (? satellite) SpectrumGreen Probe Vysis LSI ZNF217 (20q13.2) SpectrumOrange Probe Vysis LSI BCL2 Dual Color Break Apart Rearrangement Probe Vysis LSI 13q34 SpectrumGreen Probe Vysis TelVysion 8q SpectrumOrange Probe Vysis LSI PTEN SpectrumOrange / CEP 10 SpectrumGreen Probes Vysis LSI MDM2 SpectrumOrange, 20 ?L Vysis LSI BCR/ABL Dual Color, Dual Fusion DNA Probe Vysis CEP 15 (D15Z4) (? satellite) SpectrumOrange Probe Vysis LSI SS18 (18q11.2) Dual Color Break Apart Rearrangement Probe Vysis LSI ERBB2 (17q12) SpectrumGreen Probe Vysis LSI MYC (8q24) SpectrumAqua Probe Vysis TelVysion 21q SpectrumOrange Probe Vysis LSI ETV6 SpectrumOrange Probe Vysis TelVysion 6p SpectrumGreen Probe Vysis CEP 4 (? satellite) SpectrumGreen Probe Vysis CEP 7 (D7Z1) (? satellite) SpectrumGreen Probe Vysis TelVysion 4q SpectrumOrange Probe Vysis LSI MYC SpectrumGreen Probe Vysis LSI MAPT 17q21 SpectrumGreen Probe Vysis LSI IGH/CCND1 Dual Color Dual Fusion Probes Vysis LSI ETV6 (TEL) / RUNX1 (AML1) ES Dual Color Single Fusion Probe Cri-du-Chat Region Probe ? Vysis LSI D5S23, D5S721SpectrumGreen Probe Vysis LSI MLL Dual Color, Break Apart Rearrangement Probe Vysis TelVysion 19p SpectrumGreen Probe Vysis TelVysion 8p SpectrumGreen Probe Vysis LSI MYC Dual Color, Break Apart Rearrangement Probe Vysis LSI FUS (16p11) Dual Color Break Apart Rearrangement Probe Vysis Prader-Willi/Angelman Region LSI D15S11SpectrumOrange/CEP 15 SpectrumGreen Probes Vysis LSI N-MYC (2p24.1) SpectrumOrange Probe Vysis TelVysion 4p SpectrumGreen Probe Vysis LSI CCND1 Dual Color Break Apart Rearrangement Probe Vysis CEP 17 (D17Z1) (? satellite) SpectrumGreen Probe LSI SRY SpectrumOrange/CEP X SpectrumGreen DNA Probe Vysis TelVysion 18p SpectrumGreen Probe Vysis LSI ATM (11q22.3) SpectrumOrange Probe LSI D7S486 SpectrumOrange/CEP 7 SpectrumGreen DNA Probe Vysis TelVysion Xp/Yp SpectrumGreen Probe Vysis TelVysion 10p SpectrumGreen Probe Vysis LSI BCR/ABL1/ASS1 Tri-color Dual Fusion Probes (20 ?L) Vysis LSI N-MYC SpectrumGreen/CEP 2 SpectrumOrange Probes Vysis CEP 15 (D15Z1) (satellite III) SpectrumGreen Probe Vysis LSI IGH/MALT1 Dual Color Dual Fusion Probes Vysis LSI TP53 (17p13.1) SpectrumOrange Probe Vysis CEP 12 (D12Z3) (? satellite) SpectrumGreen Probe Vysis LSI D13S25 (13q14.3) SpectrumOrange Probe Vysis CEP Y (DYZ1) (satellite III) SpectrumOrange Probe Vysis LSI D5S23, D5S721 SpectrumGreen Probe Vysis LSI TOP2A 17q21-22 SpectrumOrange Probe Vysis LSI MECOM SpectrumOrange Probe CMV PRIMER ASR CMV AMP Check ASR Vysis LSI STS SpectrumOrange Probe Vysis LSI FUS (Tel) Spectrum Green Probe Vysis LSI 19p12 Spectrum Green Probe Vysis LSI FGFR2 Specturm Orange Probe Vysis LSI DDIT3 (Tel) Spectrum Green Probe Vysis LSI DDIT3 (Cen) Spectrum Orange Probe Vysis LSI ARSA Spectrum Green Probe Vysis LSI TCF3 SpectrumGreen Probe Vysis LSI RARA (Cen) SpectrumOrange Probe Vysis LSI ETV6 (Cen) SpectrumGreen Probe Vysis LSI ETV6 (Tel) SpectrumOrange Probe Vysis LSI HIRA Spectrum Orange Probe Vysis LSI NTRK1 (Cen) Spectrum Green Probe Vysis LSI 4q12 Spectrum Green Probe Vysis LSI CCND1 (Tel) Specturm Orange Probe Vysis LSI SS18 (Tel) Spectrum Orange Probe Vysis LSI BIRC3 SpectrumGreen Probe Vysis LSI CDKN2A Spectrum Orange Probe Vysis LSI CDKN2C Spectrum Green Probe Vysis LSI 4q12 Spectrum Orange Probe Vysis LSI FUS (Cen) Spectrum Orange Probe Vysis LSI FOXO1 (Cen) SpectrumGreen Probe Vysis LSI PBX1 SpectrumOrange Probe Vysis LSI ACTN4 SpectrumOrange Probe Vysis LSI CCND1 (Cen) Spectrum Green Probe Vysis LSI PTEN Spectrum Orange Probe Vysis LSI FOXO1 (Tel) SpectrumOrange Probe Vysis LSI RARA (Tel) SpectrumGreen Probe Vysis LSI SS18 (Cen) Spectrum Green Probe Vysis LSI MALT1 SpectrumOrange Probe Vysis LSI DEK Spectrum Green Probe (09N24-020) Vysis LSI NTRK1 (Tel) Spectrum Red Probe Vysis LSI CKS1B Spectrum Orange Probe Vysis LSI PDGFRA Spectrum Aqua Probe Vysis LSI NUP214 Spectrum Orange Probe (09N25-020) Vysis LSI FGFR2 (Cen) Spectrum Orange Probe (09N23-020) Vysis LSI FGFR2 (Tel) SpectrumGreenProbe (09N23-030) Vysis LSI ROS1 (Tel) SpectrumOrange Probe, 20 uL Vysis LSI ROS1 (Cen) SpectrumGreen Probe, 20 uL Vysis LSI ERG (Tel) SpectrumGreen Probe Vysis Smith-Magenis Region LSI SMS SpectrumOrange/RARA SpectrumGreen Probes Vysis LSI D13S319 SpectrumOrange/LSI 13q34 SpectrumGreen Probes Vysis CEP X (DXZ1) SpectrumGreen/Y (DYZ3) SpectrumOrange Probes Vysis LSI DDIT3 (12q13) Dual Color Break Apart Rearrangement Probe Vysis LSI CCND1 SpectrumGreen Probe Vysis TelVysion 20q SpectrumOrange Probe Vysis TelVysion 11p SpectrumGreen Probe Vysis CEP 4 (? satellite) SpectrumAqua Probe Vysis LSI ZNF217 SpectrumRed Probe Vysis LSI IGF1R SpectrumRed Probe Vysis CEP 16 (D16Z3) (satellite II) SpectrumOrange Probe Vysis LSI RUNX1 SpectrumGreen Probe Vysis LSI PDGFRB (Cen) SpectrumOrange Probe Vysis LSI CDKN2A SpectrumOrange/CEP 9 SpectrumGreen Probes Vysis CEP 16 (D16Z3) (satellite II) SpectrumAqua Probe Vysis DiGeorge Region LSI TUPLE 1 SpectrumOrange/LSI ARSA SpectrumGreen Probes Vysis MultiVysion PGT Multi-color FISH Probe Kit Vysis LSI D20S108 (20q12) SpectrumOrange Probe Vysis MultiVysion 4CC Multi-color Probe Vysis CEP Y (DYZ1) (satellite III) SpectrumAqua Probe Vysis LSI Androgen Receptor Gene (Xq12) SpectrumOrange Probe Vysis CEP 16 (D16Z3) (satellite II) SpectrumGreen Probe Vysis LSI PDGFRB (Tel) SpectrumGreen Probe Vysis CEP 7 (? satellite) (D7Z1) SpectrumOrange Probe Vysis ToTelVysion Multi-color FISH Probe Kit Vysis LSI MYC SpectrumGold Probe Vysis TelVysion 16p SpectrumGreen Probe Vysis CEP 3 (? satellite) (D3Z1) SpectrumOrange Probe Vysis CEP 6 (D6Z1) (? satellite) SpectrumOrange Probe Vysis TelVysion 7q SpectrumOrange Probe Vysis LSI 1p36 Microdeletion Region Probe Vysis TelVysion 13q SpectrumOrange Probe Vysis LSI RREB1 (6p25) SpectrumRed Probe Vysis Miller-Dieker Region/Isolated Lissencephaly LSI LIS1 SpectrumOrange/RARA SpectrumGreen Probes Vysis LSI 1p36 SpectrumOrange/1q25 SpectrumGreen Probes and Vysis LSI 19q13 SpectrumOrange/19p13 SpectrumGreen Probes Vysis Wolf-Hirschhorn Region LSI WHS SpectrumOrange/CEP 4 SpectrumGreen Probes Vysis Steroid Sulfatase Deficiency LSI STS SpectrumOrange/CEP X SpectrumGreen Probes Vysis LSI ETV6 Dual Color Break Apart Rearrangement Probe Vysis CEP 1 (D1Z5) (? satellite) SpectrumOrange Probe Vysis LSI IGH/FGFR3 Dual Color Dual Fusion Probes Vysis DiGeorge Region LSI N25 SO/ ARSA SGn Probes,10 uL Vysis LSI PML/RARA Dual Color Single Fusion Probes Vysis LSI PIK3CA SpectrumGreen Probe Vysis CEP 18 (D18Z1) (? satellite) SpectrumGreen Probe Vysis MultiVysion PB Multi-color Probes Vysis CEP 8 (D8Z2) (? satellite) SpectrumGreen Probe Vysis LSI 9q34 SpectrumAqua Probe Vysis CEP 11 (D11Z1) (? satellite) SpectrumAqua Probe Vysis TelVysion 1p SpectrumGreen Probe Vysis CEP 10 (? satellite) SpectrumAqua Probe Vysis LSI MYB (6q23) SpectrumAqua Probe Vysis CEP 17 (D17Z1) (? satellite) SpectrumAqua Probe Vysis TelVysion 15q SpectrumOrange Probe Vysis CEP X (DXZ1) (? satellite) SpectrumGreen Probe Vysis LSI MYB (6q23) SpectrumGold Probe Vysis LSI EGFR SpectrumRed Probe Vysis CEP 1 (satellite III) SpectrumOrange Probe Vysis LSI BIRC3/MALT1 Dual Color Dual Fusion Probes Vysis LSI CCND1 SpectrumOrange/CEP 11 SpectrumGreen Probes Vysis LSI 4q12 Tricolor Rearrangement Probe Vysis CEP Y (DYZ1) (satellite III) SpectrumGreen Probe Vysis TelVysion 12q SpectrumOrange Probe Vysis TelVysion 14q SpectrumOrange Probe Vysis LSI BCL6 Dual Color Break Apart Rearrangement Probe Vysis IGH/MAF Dual Color Dual Fusion DNA Probe Vysis LSI D5S23, D5S721 SpectrumGreen/CEP 9 SpectrumAqua/CEP 15 SpectrumOrange Probes Vysis TelVysion 9q SpectrumOrange Probe Vysis LSI ATM SpectrumOrange/CEP 11 Spectrum Green Probe Vysis CEP 11 (D11Z1) (? satellite) SpectrumGreen Probe Vysis LSI PML/RARA Dual Color Dual Fusion Probes Vysis TelVysion 18q SpectrumOrange Probe Vysis CEP 10 (? satellite) SpectrumOrange Probe Vysis CEP 2 (? satellite) (D2Z1) SpectrumOrange Probe Vysis LSI BCR/ABL ES Dual Color Single Fusion Probes Vysis LSI PTEN SpectrumGold Probe Vysis LSI MYC (8q24) SpectrumRed Probe Vysis LSI ZNF217 SpectrumGold Probe, 20 ?L Vysis LSI EWSR1 (22q12) Dual Color Break Apart Rearrangement Probe Vysis LSI TCF3/ PBX1 Dual Color, Dual Fusion Translocation Probe, 20 ?L Vysis LSI IGH/CCND1 XT Dual Color Dual Fusion Probes Vysis LSI MALT1 Dual Color Break Apart Rearrangement Probe Vysis TelVysion 7p SpectrumGreen Probe Vysis CEP 15 (D15Z1) (satellite III) SpectrumAqua Probe Vysis LSI KIT SpectrumRed Probe Vysis LSI EGFR SpectrumOrange/CEP 7 SpectrumGreen Probes Vysis TelVysion 5q SpectrumOrange Probe Vysis TelVysion 20p SpectrumGreen Probe Vysis MET SpectrumRed Probe Vysis LSI 13 (13q14) SpectrumGreen Probe Vysis CEP Y (DYZ3) (? satellite SpectrumOrange Probe

Establishment Types

Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device