FDA.reportPublic FDA data

Nucleic acid hybridization detection IVD, reagent

Definition
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay intended to be used for the generic detection of nucleic acid (e.g., DNA, RNA) probes hybridized to their target nucleotide sequences in a clinical specimen [e.g., fluorescent in situ hybridization (FISH), chromogenic ISH (CISH)].
GUDID devices
831
Last updated
2026-07-22 06:05:25

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
04015630967162ISH Peroxidase InhibitorVentana Medical Systems, Inc.077290140012026-07-13
00847627034380ONCORE Pro RISH™ Retrieval KitBIOCARE MEDICAL LLCOPRI6082K2022-12-21
07613336226568VENTANA® U6 DIG ProbeVentana Medical Systems, Inc.100627460012026-03-26
04015630984510BenchMark Special Stains Stainer ModuleVentana Medical Systems, Inc.064683730012025-12-15
04015630985012ISH Probe DiluentVentana Medical Systems, Inc.063753750012025-12-15
07613336160572ISH TSA Ancillary KitVentana Medical Systems, Inc.085070820012025-07-07
07613336165232VENTANA U6 ProbeVentana Medical Systems, Inc.087738660012025-07-07
05700574037420SureFISH 13q14.2 RB1 522kb P20 GRAGILENT TECHNOLOGIES, INC.G110283G2024-06-07
00615233010247Genemed®SAKURA FINETEK U.S.A., INC.10-0177-152023-06-15
00615233010292Genemed®SAKURA FINETEK U.S.A., INC.70-0031-152023-06-15
00615233010308Genemed®SAKURA FINETEK U.S.A., INC.70-0030-152023-06-15
10190302000789384-Well Background Calibration PlateLIFE TECHNOLOGIES HOLDINGS PTE. LTD.44813102023-02-08
00847627005250Mouse anti-DigoxigeninBIOCARE MEDICAL LLCBRI4049G2022-12-07
05055331316585BONDLEICA BIOSYSTEMS NEWCASTLE LTDAR92222022-12-07
05055331327802BONDLEICA BIOSYSTEMS NEWCASTLE LTDDS97902022-12-07
05700574026578MALT1 BA P20AGILENT TECHNOLOGIES, INC.G1114202022-06-21
05700574026585BCL2 BA P20AGILENT TECHNOLOGIES, INC.G1114212022-06-21
05700574026592BCL6 BA P20AGILENT TECHNOLOGIES, INC.G1114222022-06-21
05700574026608MYC BA P20AGILENT TECHNOLOGIES, INC.G1114232022-06-21
05700574026615IGH BA P20AGILENT TECHNOLOGIES, INC.G1114242022-06-21
05700574026622IGH MYC DF P20AGILENT TECHNOLOGIES, INC.G1114252022-06-21
05700574026639IGH BCL2 DF P20AGILENT TECHNOLOGIES, INC.G1114262022-06-21
05700574026646IGH CCND1 DF P20AGILENT TECHNOLOGIES, INC.G1114422022-06-21
05700574026653CCND1 BA P20AGILENT TECHNOLOGIES, INC.G1114432022-06-21
05700574026660IGH CCND1 DF P200AGILENT TECHNOLOGIES, INC.G1119312022-06-21
05700574035891SureFISH 11q21 MAML2 3' BA 399kb P100 GRAGILENT TECHNOLOGIES, INC.G110154G2022-06-13
05700574035907SureFISH 11q21 MAML2 5' BA 264kb P100 RDAGILENT TECHNOLOGIES, INC.G110155R2022-06-13
05700574035914SureFISH 17q21.33 COL1A1 DF 789kb 100 RDAGILENT TECHNOLOGIES, INC.G110156R2022-06-13
05700574035921SureFISH 22q13.1 PDGFB DF 919kb P100 GRAGILENT TECHNOLOGIES, INC.G110157G2022-06-13
05700574035938SureFISH 11q13.3 CCND1 997kb P20 GOAGILENT TECHNOLOGIES, INC.G110212Y2022-06-13
05700574035945SureFISH 1q21.3 CKS1B 386kb P20 GRAGILENT TECHNOLOGIES, INC.G110324G2022-06-13
05700574035952SureFISH 4p16.3 Chr4pTel 403kb P20 GRAGILENT TECHNOLOGIES, INC.G110348G2022-06-13
05700574035969SureFISH 4q35.2 Chr4qTel 408kb P20 GRAGILENT TECHNOLOGIES, INC.G110349G2022-06-13
05700574035976SureFISH 5p15.33 Chr5pTel 403kb P20 GRAGILENT TECHNOLOGIES, INC.G110352G2022-06-13
05700574035983SureFISH 8q24.3 Chr8qTel 397kb P20 GRAGILENT TECHNOLOGIES, INC.G110357G2022-06-13
05700574035990SureFISH 18q21.32 MALT1 DF 672kb P20 GRAGILENT TECHNOLOGIES, INC.G110374G2022-06-13
05700574036003SureFISH 17p13.1 TP53 120kb P20 GRAGILENT TECHNOLOGIES, INC.G110383G2022-06-13
05700574036010SureFISH 17p11.2 RAI1 263kb P20 GRAGILENT TECHNOLOGIES, INC.G110384G2022-06-13
05700574036027SureFISH 6p25.1 RREB1 638kb P20 GRAGILENT TECHNOLOGIES, INC.G110401G2022-06-13
05700574036034SureFISH 9p21.3 CDKN2A 351kb P20 GRAGILENT TECHNOLOGIES, INC.G110402G2022-06-13
05700574036041SureFISH 6q23 MYB 251kb P20 TRAGILENT TECHNOLOGIES, INC.G110426X2022-06-13
05700574036058SureFISH 17p13.1 TP53 247kb P20 BLAGILENT TECHNOLOGIES, INC.G110428B2022-06-13
05700574036065SureFISH 10q24.32 MGEA5 3' BA 743kb GRAGILENT TECHNOLOGIES, INC.G110429G2022-06-13
05700574036072SureFISH 1q23.1 NTRK1 5' BA 182kb P20 GRAGILENT TECHNOLOGIES, INC.G110430G2022-06-13
05700574036089SureFISH 15q25.3 NTRK3 5' BA 373kb 20 GRAGILENT TECHNOLOGIES, INC.G110431G2022-06-13
05700574036096SureFISH Xp11.4 BCOR 1009kb P20 GRAGILENT TECHNOLOGIES, INC.G110432G2022-06-13
05700574036102SureFISH 17q21.31 KANSL1 186kb P20 GRAGILENT TECHNOLOGIES, INC.G110433G2022-06-13
05700574036119SureFISH 17q11.2 NF1 332kb P20 GRAGILENT TECHNOLOGIES, INC.G110434G2022-06-13
05700574036126SureFISH 17q25.3 ASPSCR1 406kb P20 GRAGILENT TECHNOLOGIES, INC.G110435G2022-06-13
05700574036133SureFISH 1q23.1 PRCC 451kb P20 GRAGILENT TECHNOLOGIES, INC.G110436G2022-06-13
05700574036140SureFISH 5p15.31 D5S630 370kb P20 GRAGILENT TECHNOLOGIES, INC.G110437G2022-06-13
05700574036157SureFISH 4q12 FIP1L1 TC 500kb P20 GRAGILENT TECHNOLOGIES, INC.G110439G2022-06-13
05700574036164SureFISH 20q13.2 ZNF217 480kb P20 GRAGILENT TECHNOLOGIES, INC.G110440G2022-06-13
05700574036171SureFISH 11p15.4 NUP98 5’ BA 416kb 20 GRAGILENT TECHNOLOGIES, INC.G110441G2022-06-13
05700574036188SureFISH 3q26.2 MECOM 3' BA 451kb P20 GRAGILENT TECHNOLOGIES, INC.G110447G2022-06-13
05700574036195SureFISH 6q21 SEC63 241kb P20 GRAGILENT TECHNOLOGIES, INC.G110449G2022-06-13
05700574036201SureFISH 3q26.2 MECOM DF 1209kb P20 GRAGILENT TECHNOLOGIES, INC.G110451G2022-06-13
05700574036218SureFISH 17q21.1 RARA 5' BA 600kb P20 GRAGILENT TECHNOLOGIES, INC.G110452G2022-06-13
05700574036225SureFISH 6q22.1 ROS1 3' BA 1132kb P20 GRAGILENT TECHNOLOGIES, INC.G110454G2022-06-13
05700574036232SureFISH 22q11.23 BCR DF 1388kb P20 GRAGILENT TECHNOLOGIES, INC.G110455G2022-06-13
05700574036249SureFISH EWSR1 5' BA 564kb P20 GRAGILENT TECHNOLOGIES, INC.G110456G2022-06-13
05700574036256SureFISH 18q11.2 SS18 3’ BA 616kb P20 GRAGILENT TECHNOLOGIES, INC.G110457G2022-06-13
05700574036263SureFISH 8q24.21 MYC 5' BA 632kb P20 GRAGILENT TECHNOLOGIES, INC.G110458G2022-06-13
05700574036270SureFISH Xp11.23 TFE3 5' BA 237kb P20 RDAGILENT TECHNOLOGIES, INC.G110459R2022-06-13
05700574036287SureFISH Xp11.23 TFE3 3' BA 540kb P20 GRAGILENT TECHNOLOGIES, INC.G110460G2022-06-13
05700574036294SureFISH 3q27.3 BCL6 DF 785kb P20 GRAGILENT TECHNOLOGIES, INC.G110462G2022-06-13
05700574036300SureFISH 22q12.2 EWSR1 DF 740kb P20 GRAGILENT TECHNOLOGIES, INC.G110463G2022-06-13
05700574036317SureFISH 11q24.3 FLI1 DF 770kb P20 RDAGILENT TECHNOLOGIES, INC.G110464R2022-06-13
05700574036324SureFISH 6q23.3 MYB DF 500kb P20 RDAGILENT TECHNOLOGIES, INC.G110465R2022-06-13
05700574036331SureFISH 9p23 NFIB DF 500kb P20 GRAGILENT TECHNOLOGIES, INC.G110466G2022-06-13
05700574036348SureFISH 2q13 PAX8 DF 326kb P20 RDAGILENT TECHNOLOGIES, INC.G110467R2022-06-13
05700574036355SureFISH 3p25.2 PPARG DF 326kb P20 GRAGILENT TECHNOLOGIES, INC.G110468G2022-06-13
05700574036362SureFISH 8p11.23 FGFR1 3’ BA 393kb 20 GRAGILENT TECHNOLOGIES, INC.G110469G2022-06-13
05700574036379SureFISH 8p11.22 FGFR1 5’ BA 515kb 20 RDAGILENT TECHNOLOGIES, INC.G110470R2022-06-13
05700574036386SureFISH 4p16.3 FGFR3 3' BA 373kb P20 GRAGILENT TECHNOLOGIES, INC.G110471G2022-06-13
05700574036393SureFISH 4p16.3 FGFR3 5' BA 316kb P20 RDAGILENT TECHNOLOGIES, INC.G110472R2022-06-13
05700574036409SureFISH 19q13.32 BCL3 DF 565kb P20 RDAGILENT TECHNOLOGIES, INC.G110473R2022-06-13
05700574036416SureFISH 19q13.32 FOSB 5' BA 430kb 20 GRAGILENT TECHNOLOGIES, INC.G110474G2022-06-13
05700574036423SureFISH 19q13.32 FOSB 3' BA 619kb 20 RDAGILENT TECHNOLOGIES, INC.G110475R2022-06-13
05700574036430SureFISH 11q13.1 C11orf95 5' 504kb 20 GRAGILENT TECHNOLOGIES, INC.G110476G2022-06-13