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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 3 of 24
DeviceModel / ReferenceRegistriesClassStatus
Myc Ba P20 G111423
FDA UDI
Class IActive
50ts8qia 50TS8QIA
FDA UDI
Class IActive
SureFISH 4q12 KIT 155kb P20 RD G110257R
FDA UDI
Class IActive
SureFISH Chr18 CEP 711kb P20 GR G110874G
FDA UDI
Class IActive
Igh Ba P20 G111424
FDA UDI
Class IActive
FLEX Mono Mo A-Hu Cytokeratin High Molecular Weight Cl 34ßE12 RTU (Dako Omnis) GA051
FDA UDI
Class IActive
SureFISH Chr13 CEP 454kb P20 GR G110870G
FDA UDI
Class IActive
SureFISH 1q25.2 ABL2 5’ BA 571kb P20 RD G110417R
FDA UDI
Class IActive
Slxf-Si SLXF-SI
FDA UDI
Class IActive
C10mphc2-Si C10MPHC2-SI
FDA UDI
Class IActive
Mono Mo A-Thrombomodulin Cl 1009 M0617
FDA UDI
Class IUnknown
N2sma-Si N2SMA-SI
FDA UDI
Class IActive
Artisan Alpha Amylase AR171
FDA UDI
Class IUnknown
FLEX Mono Rb A-Hu Cytokeratin 8/18 Cl EP17/30 RTU (Link) IR094
FDA UDI
Class IActive
SureFISH NTRK3 3' 390kb P20 RD G110215R
FDA UDI
Class IActive
SureFISH 21q22.3 TMPRSS2 DF 873kb P5GRx6 G210914G
FDA UDI
Class IUnknown
Lp620-Si LP620-SI
FDA UDI
Class IActive
FLEX Mono Mo A-Hu CDX2 Cl DAK-CDX2 RTU (Link) IR080
FDA UDI
Class IActive
SureFISH 3q27.3 BCL6 5’ BA 491kb P5 RD G110927R
FDA UDI
Class IUnknown
SureFISH 8p12 NRG1 5' BA 460kb P20 GR G110219G
FDA UDI
Class IActive
SureFISH 7q31.2 MET 400kb P100 RD G110118R
FDA UDI
Class IActive
SureFISH Chr10 CEP 676kb P20 GR G110884G
FDA UDI
Class IActive
SureFISH 3q27.3 BCL6 5’ BA 491kb P5 RD6 G210927R
FDA UDI
Class IUnknown
Mono Mo A-Hu IMP3 Cl 69.1 M3626
FDA UDI
Class IActive
FLEX Mono Mo A-Hu CD5 Cl 4C7 RTU (Link) IR082
FDA UDI
Class IActive
SureFISH 12q13 DDIT3 3' BA 537kb P20GRX5 G210982G
FDA UDI
Class IUnknown
SureFISH TCRAD 5' BA 468kb P20 GR G110364G
FDA UDI
Class IActive
28S rRNA CISH Probe G111922
FDA UDI
Class IActive
SureFISH 21q22.3 Chr21qTel 394kb P20 GR G110838G
FDA UDI
Class IUnknown
SureFISH 17q12 HER2 191kb P5GRx6 G210909G
FDA UDI
Class IUnknown
SureFISH 22q11.23 SMARCB1 98kb P20 RD G110232R
FDA UDI
Class IActive
SureFISH 3p26.3 Chr3pTel 381kb P20 BL G110860B
FDA UDI
Class IUnknown
Cyt1fa-Si CYT1FA-SI
FDA UDI
Class IActive
SureFISH 22q13.1 PDGFB DF 919kb P20 GR G110734G
FDA UDI
Class IActive
SureFISH 1p36.23 CAMTA1 647kb P20 RD G110216R
FDA UDI
Class IActive
SureFISH 14q32.33 IGH DF 1519kb P20 GR G110995G
FDA UDI
Class IActive
SureFISH 1p36.33 Chr1pTel 417kb P20 BL G110882B
FDA UDI
Class IUnknown
SureFISH 3q21.3 RPN1 DF 558kb P20 RD G110382R
FDA UDI
Class IActive
Cyt7um-Si CYT7UM-SI
FDA UDI
Class IActive
Mono Mo A-Hu Calponin Cl CALP M3556
FDA UDI
Class IActive
Lp640-Si LP640-SI
FDA UDI
Class IActive
SureFISH 18q21 BCL2 3' BA 624kb P5 GR6 G210938G
FDA UDI
Class IUnknown
FLEX Mono Mo A-Hu CD99, MIC2 Gene Product Ewing’s Sarcoma Marker Cl 12E7 RTU IS057
FDA UDI
Class IUnknown
SureFISH 7q34 KIAA1549 150kb P20 GR G110750G
FDA UDI
Class IActive
FLEX Universal Negative Control Mo RTU (Dako Omnis) GA750
FDA UDI
Class IActive
Mono Rb A-Hu MutS Protein Homolog 6 Cl EP49 M3646
FDA UDI
Class IActive
SureFISH 18q21.33 BCL2 3’ BA 389kb P5GR6 G210924G
FDA UDI
Class IUnknown
Mono Mo A-Hu Progesterone Receptor, Cl PgR 1294 M3568
FDA UDI
Class IIUnknown
SureFISH 10q23.31 PTEN 160kb P100 RD G110123R
FDA UDI
Class IActive
SureFISH 21q22.2 ERG 5p BA 552kb P5RDx6 G210916R
FDA UDI
Class IUnknown

Related Companies

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Importers

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Notified Bodies

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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