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Agilent Technologies Inc.

United States·US-MF-000009385

Last updated September 17, 2026

Information

Country
United States
Address
5301, Stevens Creek Blvd., Santa Clara, United States
Website
www.agilent.com
LinkedIn
—
Facebook
—
Email
[email protected]
Phone
+45 44859756
PRRC Contact
Grace Lee
EUDAMED SRN
US-MF-000009385
FDA FEI Number
3009189893
DUNS Number
—

Catalogue (1184)

Page 15 of 24
DeviceModel / ReferenceRegistriesClassStatus
FLEX Mono Mo A-Hu Octamer-Binding Transcription Factor 3/4 Cl N1NK RTU (Link) IR092
FDA UDI
Class IActive
SureFISH 1p36.32 TPRG1L 332kb P100 RD G110102R
FDA UDI
Class IActive
SureFISH 17p11.2 RAI1 263kb P100 GR G110137G
FDA UDI
Class IActive
SureFISH 5q32 CSF1R 5' BA 465kb P20 RD G110411R
FDA UDI
Class IActive
SureFISH 16q23.2 MAF DF 604kb P20 RD G110388R
FDA UDI
Class IActive
SureFISH Chr7 CEP 767kb P20 BL G110899B
FDA UDI
Class IActive
Mono Rb A-Hu MutS Protein Homolog 6 Cl EP49 M3646
FDA UDI
Class IActive
SureFISH DUSP22 IRF4 5' 48kb P100 RD G110131R
FDA UDI
Class IActive
SureFISH 19q13.32 BCL3 DF 565kb P20 RD G110473R
FDA UDI
Class IActive
SureFISH 18q21.32 MALT1 DF 672kb P20 GR G110374G
FDA UDI
Class IActive
SureFISH BCL6 BA P200 G111925
FDA UDI
Class IActive
SureFISH Xp11.23 TFE3 5' BA 237kb 100 RD G110148R
FDA UDI
Class IActive
SureFISH Chr1 CEP 541kb P20 GR G110831G
FDA UDI
Class IActive
FLEX Mono Mo A-Hu Caldesmon Cl h-CD RTU IS054
FDA UDI
Class IUnknown
SureFISH 5p15.33 Chr5pTel 403kb P20 BL G110891B
FDA UDI
Class IUnknown
FLEX Mono Mo A-Hu Mammaglobin Cl 304-1A5 RTU (Dako Omnis) GA074
FDA UDI
Class IActive
Dako A0566
FDA UDI
Class IActive
SureFISH 2p11.2 IGK 5' BA 1063kb P20 GR G110732G
FDA UDI
Class IActive
SureFISH 17p13.2 USP6 5' BA 400kb P20 GR G110711G
FDA UDI
Class IActive
SureFISH 16p11.2 FUS 5' BA 457kb GR G110929G
FDA UDI
Class IUnknown
SureFISH 13q34 LAMP1 598kb P20 GR G110800G
FDA UDI
Class IActive
N2mb-Si N2MB-SI
FDA UDI
Class IActive
SureFISH PDGFD BA 5’ BA 350kb P20 GR G110407G
FDA UDI
Class IActive
MMR Negative Control Reagent, Rabbit (Dako Omnis) GE102
FDA UDI
Class IIIActive
SureFISH 2p23.2 ALK 479kb P5 RD6 G210919R
FDA UDI
Class IUnknown
SureFISH 12q14.1 CDK4 308kb P20RD G110978R
FDA UDI
Class IActive
FLEX Mono Mo A-Hu Cytokeratin Cl AE1/AE3 RTU (Link) IR053
FDA UDI
Class IActive
SureFISH 21q22.3 TMPRSS2 DF 873kb P5RDx6 G210914R
FDA UDI
Class IUnknown
50ts8-Si 50TS8-SI
FDA UDI
Class IActive
ELx808IU-SI ELx808IU-SI
FDA UDI
Class IActive
SureFISH 8q24.21 MYC 294kb P20BL G110977B
FDA UDI
Class IUnknown
SureFISH 10q11 RET 5' BA 439kb P20 RD5 G210984R
FDA UDI
Class IUnknown
FLEX Mono Mo A-Hu Prostein Cl 10E3 RTU (Link) IR088
FDA UDI
Class IActive
SureFISH 12q14.1 DDIT3 5' BA 498kb P5 GR G110923G
FDA UDI
Class IUnknown
MSH2 IHC pharmDx (Dako Omnis) GE085
FDA UDI
Class IIIActive
SureFISH 3q26.2 MECOM 5' TC 437kb P20 BL G110806B
FDA UDI
Class IActive
SureFISH Chr17 CEP 436kb P20BL G110972B
FDA UDI
Class IActive
SureFISH 3q28 BCL6 5’ BA 481kb GR6 G210931G
FDA UDI
Class IUnknown
ELx405V-SI ELx405V-SI
FDA UDI
Class IActive
C10mpw-Si C10MPW-SI
FDA UDI
Class IActive
SureFISH Chr15 CEP 265kb P20 GR G110872G
FDA UDI
Class IActive
SureFISH 19p13.11 CRTC1 DF 500kb P20 GR G110479G
FDA UDI
Class IActive
Artisan User Fillable Dispenser #1 AR185
FDA UDI
Class IUnknown
SureFISH TFE3 5' BA 237kb P5RD G110906R
FDA UDI
Class IUnknown
50ts16v-Si 50TS16V-SI
FDA UDI
Class IActive
SureFISH Chr13 CEP 454kb P20 BL G110870B
FDA UDI
Class IActive
FLEX Mono Mo A-Hu Progesterone Receptor Cl PgR 1294 RTU (Dako Omnis) GA090
FDA UDI
Class IIActive
SureFISH Chr7 CEP P5GRx6 G210902G
FDA UDI
Class IUnknown
Llxw-Si LLXW-SI
FDA UDI
Class IActive
SureFISH 12q13 DDIT3 3' BA 537kb P100 GR G110114G
FDA UDI
Class IActive

Related Companies

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Importers

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Authorities

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FDA Recalls (5)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

DateRecall No.ClassStatusReason
Mar 20, 2025Z-1544-2025—open, classified

DNA Labeling Kit for use in sample labeling to be hybridized to oligonucleotide microarrays has a component, Human Reference DNA Female aliquot, affected by a mosaic aberration that may result in Chromosome 12 baseline shift, which may lead to false positive/negative results, resulting in diagnosis delay, and may lead to delayed treatment of a treatable genetic disorder.

Apr 2, 2024Z-1919-2024—open, classified

There is the potential for the front plexiglass door of the automated slide processing system to break causing potential injury.

May 20, 2022Z-1384-2022—open, classified

Label provided for substrate vail contained incorrect expiration date.

Aug 15, 2018Z-2359-2019—terminated

When utilizing specific software versions of an LC/MS device, and Batch at a Glance in Compound Table view, a defect occurs when a new sample(s) is inserted. This defect creates a mismatch between the sample name and the column header whereby the sample header will be offset by one sample. The recalling firm requests that you discontinue using this workflow to generate reports because the Quant batch table will not display fully analyzed results or save any changes made.

Jun 17, 2015Z-1737-2017—terminated

The product was marketed without 510(k) clearance.

FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

  • Agilent Technologies Waldbronn Baden-Wurttemberg · DE FEI 3009202467