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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 23 of 24
DeviceModel / ReferenceRegistriesClassStatus
SureFISH FOXO1 5' BA 601kb P5 RD G110905R
FDA UDI
Class IUnknown
SureFISH 13q34 Chr13qTel 357kb P20 GR G110841G
FDA UDI
Class IUnknown
SureFISH Chr12 CEP 704kb P100 GR G110109G
FDA UDI
Class IActive
50ts8m-Si 50TS8M-SI
FDA UDI
Class IActive
SureFISH 4q12 PDGFRA-CN 155kb P20 RD G110740R
FDA UDI
Class IActive
SureFISH CCND1 DF 577kb P20 BL G110819B
FDA UDI
Class IUnknown
Mono Mo A-Hu Tyrosinase Cl T311 M3623
FDA UDI
Class IUnknown
FLEX Mono Mo A-Hu CD1a Cl 010 RTU IS069
FDA UDI
Class IUnknown
SureFISH 11q13.3 CCND1 997kb P20 GO G110212Y
FDA UDI
Class IActive
SureFISH 5p15.33 TERT 1107kb P20 RD G110210R
FDA UDI
Class IUnknown
SureFISH 10q11.21 RET 3' BA 623kb P5 GR G110935G
FDA UDI
Class IUnknown
FLEX Mono Mo A-Hu Gross Cystic Disease Fluid Protein-15 Cl 23A3 RTU (Dako Omnis) GA077
FDA UDI
Class IActive
Mono Mo A-Hu Epidermal Growth Factor Receptor (EGFR) Cl: H11 M3563
FDA UDI
Class IUnknown
Artisan Alpha Amylase AR171
EUDAMEDFDA UDI
Class IActive
SureFISH 16p13.3 Chr16pTel 428kb P20 GR G110876G
FDA UDI
Class IUnknown
SureFISH 1q22 NTRK1 5' BA 478kb P20 GR G110719G
FDA UDI
Class IActive
SureFISH 10p11.22 KIF5B DF 788kb RD G110932R
FDA UDI
Class IUnknown
SureFISH Chr20 CEP 687kb P20 RD G110277R
FDA UDI
Class IActive
FLEX Mono Mo A-Hu CD5 Cl 4C7 RTU IS082
FDA UDI
Class IUnknown
SureFISH NTRK1 5' BA 478kb P100 GR G110125G
FDA UDI
Class IActive
SureFISH ROS1-GOPC 3' BA 1132kb P100 GR G110135G
FDA UDI
Class IActive
SureFISH 17p12 PMP22 458kb P20 RD G110342R
FDA UDI
Class IActive
SureFISH 17q21.1 RARA 5' BA 600kb P20 GR G110452G
FDA UDI
Class IActive
SureFISH Chr11 CEP 798kb P20 GR G110883G
FDA UDI
Class IActive
SureFISH TFE3 5' BA 237kb P5RDx6 G210906R
FDA UDI
Class IUnknown
SureFISH 6p25.3 Chr6pTel 423kb P20 RD G110381R
FDA UDI
Class IUnknown
SureFISH 10p15.3 Chr10pTel 372kb P20 BL G110856B
FDA UDI
Class IUnknown
SureFISH 17p13.3 Chr17pTel 402kb P20 BL G110842B
FDA UDI
Class IUnknown
SureFISH 6q27 Chr6qTel 390kb P20 BL G110894B
FDA UDI
Class IUnknown
N2mab-Si N2MAB-SI
FDA UDI
Class IActive
Bstck3wr-Si BSTCK3WR-SI
FDA UDI
Class IActive
406psub3-Si 406PSUB3-SI
FDA UDI
Class IActive
405lsrv-Si 405LSRV-SI
FDA UDI
Class IActive
FLEX Mono Mo A-Hu CD15 Cl Carb-3 RTU IS062
FDA UDI
Class IUnknown
SureFISH 3q29 Chr3qTel 380kb P20 BL G110853B
FDA UDI
Class IUnknown
SureFISH 3q26.2 MECOM DF 1209kb P20 GR G110451G
FDA UDI
Class IActive
Agilent CytoDx Software K1203-10000
EUDAMED
Class CActive
Synergy HTX S1LA-SI
EUDAMEDFDA UDI
Class AActive
Synergy H1 H1M2F-SI
EUDAMEDFDA UDI
Class AActive
Epoch 2 Epoch2TS-SI
EUDAMEDFDA UDI
Class AActive
GenetiSure Dx Cot-1 Human DNA K1201-64400
EUDAMEDFDA UDI
Class AActive
Synergy H1 SH1MF-SI
EUDAMEDFDA UDI
Class AActive
Zymed Telemetry System K980186
FDA 510(k)
Class IIActive
Digital Holter Recorder K942781
FDA 510(k)
Class IIActive
Zymed Telemetry System: Model Easiview K990093
FDA 510(k)
Class IIActive
2010 Plus Holter For Windows K010949
FDA 510(k)
Class IIActive
Agilentcomponent Monitoring System, Agilent 24/26, Agilent Multi-Measurement Server And Compact Portable Patient Monitor K000822
FDA 510(k)
Class IIActive
2010 Plus Holter For Windows K003763
FDA 510(k)
Class IIActive
Modification To Agilent Technologies Anesthesia Gas Monitor, Model M1026a #co5 K994188
FDA 510(k)
Class IIActive
Quikpage Scanner K822582
FDA 510(k)
Class IIActive

Related Companies

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Importers

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Notified Bodies

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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