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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 2 of 24
DeviceModel / ReferenceRegistriesClassStatus
SureFISH 22q13.33 SHANK3 70kb P20 GR G110737G
FDA UDI
Class IActive
FLEX Mono Mo A-Hu Caldesmon, Cl h-CD, RTU (Dako Omnis) GA054
FDA UDI
Class IActive
406psu0lb-Si 406PSU0LB-SI
FDA UDI
Class IActive
SureFISH ALK 3' BA 300kb P5GR G110908G
FDA UDI
Class IUnknown
SureFISH 5q35.3 Chr5qTel 397kb P20 RD G110353R
FDA UDI
Class IUnknown
SureFISH Xp22/Yp11 CRLF2 3' BA P20 RD G110979R
FDA UDI
Class IActive
Poly Rb A-Hu CD117, c-kit A4502
FDA UDI
Class IActive
SureFISH 1q23.1 NTRK1 3' BA 380kb P20 RD G110720R
FDA UDI
Class IActive
SureFISH 9p21.3 CDKN2A 351kb P20GO G110973Y
FDA UDI
Class IActive
SureFISH 12q13.3 DDIT3 3'BA 537kb P5 GR6 G210922G
FDA UDI
Class IUnknown
SureFISH 2p25.3 Chr2pTel 391kb P20 BL G110859B
FDA UDI
Class IUnknown
SureFISH Xp22/Yp11 CRLF2 5' BA P20 GR G110980G
FDA UDI
Class IActive
SureFISH 17q21.2 RARA 3' BA 419kb P20 RD G110282R
FDA UDI
Class IActive
Mfxp2-Si MFXP2-SI
FDA UDI
Class IActive
SureFISH 7p11.2 EGFR 188kb P100 RD G110120R
FDA UDI
Class IActive
SureFISH Chr3 CEP 592kb P20TR G210974X
FDA UDI
Class IUnknown
SureFISH 13q34 Chr13qTel 357kb P20 RD G110337R
FDA UDI
Class IUnknown
SureFISH 16p11.2 FUS 5' BA 457kb GR6 G210929G
FDA UDI
Class IUnknown
ELx405-SI ELx405-SI
FDA UDI
Class IActive
SureFISH ALK BA P200 G111900
FDA UDI
Class IActive
SureFISH 5q35.3 NSD1 321kb P20 RD G110375R
FDA UDI
Class IActive
SureFISH Xp22/Yp11 CRLF2 3' BA P20RDX5 G210979R
FDA UDI
Class IUnknown
50ts8mv-Si 50TS8MV-SI
FDA UDI
Class IActive
Mono Mo A-Hu CD1a Cl 010 M3571
FDA UDI
Class IUnknown
SureFISH 7q34 TRB 3' BA 390kb P20 RD G110700R
FDA UDI
Class IActive
SureFISH 12q15 MDM2 180kb P20 RD G110393R
FDA UDI
Class IActive
SureFISH 8q24.3 Chr8qTel 397kb P20 GR G110357G
FDA UDI
Class IUnknown
SureFISH 3q28 TP63 3’ BA 443kb P20 GR G110715G
FDA UDI
Class IActive
K6460 Triple Quadrupole MS – AJS K6460 Triple Quadrupole MS – AJS
FDA UDI
Class IActive
SureFISH 5q35.3 Chr5qTel 397kb P20 BL G110892B
FDA UDI
Class IUnknown
SureFISH Chr9 CEP 367kb P20 RD G110266R
FDA UDI
Class IActive
FLEX Universal Negative Control Rb RTU (Dako Omnis) GA600
FDA UDI
Class IActive
C10phc2-Si C10PHC2-SI
FDA UDI
Class IActive
FLEX Negative Control Mo Cocktail of Mo IgG1, IgG2a, IgG2b, IgG3, IgM RTU (Link) IR750
FDA UDI
Class IActive
SureFISH CCND1 BA P200 G111926
FDA UDI
Class IActive
Igh Bcl2 Df P20 G111426
FDA UDI
Class IActive
SureFISH ROS1 BA P5 G111201
FDA UDI
Class IUnknown
SureFISH ALK 3' BA 300kb P5RDx6 G210908R
FDA UDI
Class IUnknown
Cyt5m-Si CYT5M-SI
FDA UDI
Class IActive
Sh1fselux SH1FSELUX
FDA UDI
Class IActive
SureFISH 10q11.21 RET 5' BA 439kb P20 RD G110984R
FDA UDI
Class IUnknown
PD-L1 IHC 22C3 pharmDx GE006
FDA UDI
Class IIIActive
405tsu-Si 405TSU-SI
FDA UDI
Class IActive
Cyt7u-Si CYT7U-SI
FDA UDI
Class IActive
SureFISH 7q11.23 ELN-LIMK1 104kb P20 RD G110744R
FDA UDI
Class IUnknown
Mono Mo A-Thyroid Transcription Factor (TTF-1) Cl 8G7G3/1 M3575
FDA UDI
Class IActive
SureFISH Chr15 CEP 265kb P20 RD G110269R
FDA UDI
Class IActive
SureFISH 7p12.2 IKZF1 50kb P20 RD G110302R
FDA UDI
Class IActive
405tsrvsq-Si 405TSRVSQ-SI
FDA UDI
Class IActive
N2mat-Si N2MAT-SI
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