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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 19 of 24
DeviceModel / ReferenceRegistriesClassStatus
SureFISH TGFBR3 5' BA 621kb P20 GR G110208G
FDA UDI
Class IActive
Mono Mo A-Hu MITF (Microphthalmia Transcription Factor) Cl D5 M3621
FDA UDI
Class IActive
SureFISH JAK2 3' BA 503kb P20 GR G110201G
FDA UDI
Class IActive
SureFISH 1q25.2 ABL2 600kb P20 GR G110891G
FDA UDI
Class IActive
SureFISH 14q11 TCRAD 5' BA 468kb P5 GR6 G210936G
FDA UDI
Class IUnknown
N2at-Si N2AT-SI
FDA UDI
Class IActive
SureFISH 5q35.1 TLX3 5' BA 325kb P20 RD G110368R
FDA UDI
Class IActive
SureFISH 6p25.3 Chr6pTel 423kb P20 BL G110839B
FDA UDI
Class IUnknown
Mono Mo A-Hu Luteinizing Hormone (LH) Cl C93 M3502
FDA UDI
Class IUnknown
SureFISH 1p36 MORN1-TNFRSF14 297kb GR G110753G
FDA UDI
Class IActive
SureFISH 6q22.1 ROS1 5' BA 245kb P20 RD G110389R
FDA UDI
Class IActive
406psub2lb-Si 406PSUB2LB-SI
FDA UDI
Class IActive
SureFISH Chr17 CEP 436kb P5RDx6 G210910R
FDA UDI
Class IUnknown
SureFISH IGH BA P200 G111928
FDA UDI
Class IActive
FLEX Mono Mo A-Hu Gross Cystic Disease Fluid Protein-15 Cl 23A3 RTU (Link) IR077
FDA UDI
Class IUnknown
FLEX Mono Mo A-Hu Podoplanin Cl D2-40 RTU IS072
FDA UDI
Class IUnknown
SureFISH 20q13.33 Chr20qTel 379kb P20 GR G110849G
FDA UDI
Class IUnknown
405tsr-Si 405TSR-SI
FDA UDI
Class IActive
SureFISH YWHAE 5' BA 261kb P20 RD G110224R
FDA UDI
Class IActive
Slxa-Si SLXA-SI
FDA UDI
Class IActive
SureFISH 8p23.3 Chr8pTel 406kb P20 RD G110356R
FDA UDI
Class IUnknown
SureFISH 4p16.3 SPON2 378kb P20 RD G110327R
FDA UDI
Class IActive
SureFISH 3q28 BCL6 5’ BA 481kb P20 GR G110991G
FDA UDI
Class IUnknown
Mono Mo A-Hu Mesothelial Cell Cl HBME-1 M3505
FDA UDI
Class IActive
SureFISH 4p16.3 FGFR3 5' BA 316kb P20 RD G110472R
FDA UDI
Class IActive
SureFISH ChrY CEP 273kb P20 GR G110863G
FDA UDI
Class IActive
SureFISH FOXO1 3' BA 600kb P20 GR5 G210986G
FDA UDI
Class IUnknown
SureFISH BCL2 BA P200 G111924
FDA UDI
Class IActive
SureFISH 18q21.33 BCL2 3’ BA 389kb P5 RD G110924R
FDA UDI
Class IUnknown
PMS2 IHC pharmDx (Dako Omnis) GE087
FDA UDI
Class IIIActive
SureFISH Chr3 CEP 592kb P20TR G110974X
FDA UDI
Class IActive
SureFISH 1q25.2 ABL2 3’ BA 464kb P20 GR G110418G
FDA UDI
Class IActive
SureFISH 8q12.1 PLAG1 5' BA 400kb 100 GR G110153G
FDA UDI
Class IActive
SureFISH 11q13.1 C11orf95 5' 504kb 20 GR G110476G
FDA UDI
Class IUnknown
SureFISH 8q13.3 NCOA2 3' BA 608kb P20 GR G110223G
FDA UDI
Class IUnknown
SureFISH 12q24.33 Chr12qTel 424kb P20 GR G110835G
FDA UDI
Class IUnknown
SureFISH 13q14.2 RB1 522kb P20 GR G110283G
FDA UDI
Class IActive
SureFISH 16q24.3 Chr16qTel 424kb P20 RD G110340R
FDA UDI
Class IUnknown
SureFISH 17q12 HER2 191kb P20 RD G110390R
FDA UDI
Class IActive
SureFISH 2q37.3 Chr2qTel 415kb P20 BL G110885B
FDA UDI
Class IUnknown
SureFISH 17p13.2 USP6 3' BA 385kb P20 RD G110710R
FDA UDI
Class IActive
SureFISH 15q26.3 Chr15qTel 391kb P20 GR G110855G
FDA UDI
Class IUnknown
Cyt5pw-Si CYT5PW-SI
FDA UDI
Class IActive
SureFISH 5q32 CSF1R 3' BA 402kb P20 GR G110410G
FDA UDI
Class IActive
Lp560-Si LP560-SI
FDA UDI
Class IActive
SureFISH 16q22.1 CBFB DF 498kb P20 GR G110422G
FDA UDI
Class IUnknown
MLH1 IHC pharmDx (Dako Omnis) GE079
FDA UDI
Class IIIActive
SureFISH 2p24 MYCN 277kb P5 RD6 G210921R
FDA UDI
Class IUnknown
SureFISH 7p12.2 IKZF1 62kb P20 RD G110220R
FDA UDI
Class IActive
SureFISH 17q12 HER2 191kb P5RDx6 G210909R
FDA UDI
Class IUnknown

Related Companies

Authorised Representatives

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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