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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 14 of 24
DeviceModel / ReferenceRegistriesClassStatus
FLEX Mono Mo A-Hu Caldesmon Cl h-CD RTU (Link) IR054
FDA UDI
Class IActive
SureFISH 20q13.2 ZNF217 480kb P100 GO G110140Y
FDA UDI
Class IUnknown
SureFISH 7p22.3 Chr7pTel 426kb P20 RD G110355R
FDA UDI
Class IUnknown
SureFISH 8p11.22 FGFR1 5’ BA 515kb 20 RD G110470R
FDA UDI
Class IActive
Cyt5w-Si CYT5W-SI
FDA UDI
Class IActive
SureFISH 6p21.1 TFEB 3' BA 323kb P20 GR G110243G
FDA UDI
Class IActive
SureFISH Chr3 CEP 592kb P20 BL G110865B
FDA UDI
Class IActive
SureFISH 2p21 EML4 496kb P5 RD G110920R
FDA UDI
Class IUnknown
SureFISH 6q23.3 MYB 3' BA 394kb P100 GR G110151G
FDA UDI
Class IActive
SureFISH 7q31.2 MET 400kb P20 RD G110994R
FDA UDI
Class IActive
SureFISH 16p11.2 KCTD13 548kb P20 RD G110362R
FDA UDI
Class IUnknown
Mono Mo A-Hu CD15 Cl Carb-3 M3631
FDA UDI
Class IActive
SureFISH 12q14.1 DDIT3 5' BA 498kb P5 RD G110923R
FDA UDI
Class IUnknown
SureFISH 17p13.1 TP53 120kb P20 RD G110383R
FDA UDI
Class IActive
Mono Rb A-Hu Postmeiotic Segregation Increased 2 Cl EP51 M3647
FDA UDI
Class IActive
SureFISH 22q11.22 IGL DF 1776kb P20 GR G110416G
FDA UDI
Class IActive
SureFISH 4p16.3 Chr4pTel 403kb P20 RD G110348R
FDA UDI
Class IUnknown
SureFISH D20S108 20q12 200kb P20 RD G110247R
FDA UDI
Class IActive
SureFISH DUSP22-IRF4 3' 235kb P100 GR G110132G
FDA UDI
Class IActive
SureFISH Chr12 CEP 704kb P20 RD G110281R
FDA UDI
Class IActive
Kappa mRNA CISH Probe G111919
FDA UDI
Class IActive
SureFISH 15q25.3 NTRK3 5' BA 373kb 20 GR G110431G
FDA UDI
Class IActive
SureFISH 1p36.33 Chr1pTel 417kb P20 RD G110343R
FDA UDI
Class IUnknown
SureFISH EWSR1 5' BA 564kb P100 GR G110107G
FDA UDI
Class IActive
Bstck4-Si BSTCK4-SI
FDA UDI
Class IActive
SureFISH Chr22 CEP 668kb P20 RD G110279R
FDA UDI
Class IActive
SureFISH 15q11.2 SNRPN 232kb P20 RD G110328R
FDA UDI
Class IActive
FLEX Mono Rb A-Hu MutS Protein Homolog 6 Cl EP49 RTU (Link) IR086
FDA UDI
Class IActive
SureFISH ChrY CEP 273kb P20 BL G110863B
FDA UDI
Class IActive
SureFISH 15q11.2 D15S11 135kb P20 RD G110297R
FDA UDI
Class IActive
SureFISH 12q14 DDIT3 5' BA 498kb P20RD G110983R
FDA UDI
Class IActive
SureFISH Chr8 635kb CEP P20 RD G110248R
FDA UDI
Class IActive
SureFISH 1p36 AJAP1 303kb P20 GR G110754G
FDA UDI
Class IActive
SureFISH 17q25.3 Chr17qTel 405kb P20 GR G110843G
FDA UDI
Class IUnknown
FLEX Mono Rb A-Hu Cyclin D1 Cl EP12 RTU IS083
FDA UDI
Class IUnknown
405lsrvsq-Si 405LSRVSQ-SI
FDA UDI
Class IActive
SureFISH 11q25 Chr11qTel 398kb P20 BL G110837B
FDA UDI
Class IUnknown
Lfxbio LFXBIO
FDA UDI
Class IActive
Cyt7umw-Si CYT7UMW-SI
FDA UDI
Class IActive
SureFISH 11q22.2 BIRC3 DF 674kb P20 RD G110373R
FDA UDI
Class IActive
FLEX Mono Mo A-Hu Mammaglobin Cl 304-1A5 RTU (Link) IR074
FDA UDI
Class IActive
Mono Rb A-Hu Cyclin D1 Cl EP12 M3642
FDA UDI
Class IUnknown
SureFISH NTRK3 5' BA 481kb P100 GR G110130G
FDA UDI
Class IActive
SureFISH 9q34.12 ABL DF 640kb P20 RD G110391R
FDA UDI
Class IActive
SureFISH 17q11.2 NF1 332kb P20 GR G110434G
FDA UDI
Class IActive
N2mabt-Si N2MABT-SI
FDA UDI
Class IActive
SureFISH NTRK2 3' BA 445kb P100 RD G110127R
FDA UDI
Class IActive
Cyt5mv-Si CYT5MV-SI
FDA UDI
Class IActive
SureFISH 10q26 FGFR2 360kb P20RDX5 G210981R
FDA UDI
Class IUnknown
SureFISH 19q13.32 FOSB 3' BA 619kb 20 RD G110475R
FDA UDI
Class IActive

Related Companies

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Importers

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Authorities

Not available yet.

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