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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 20 of 24
DeviceModel / ReferenceRegistriesClassStatus
ELx405S-SI ELx405S-SI
FDA UDI
Class IActive
SureFISH ROS1 BA P20 G111401
FDA UDI
Class IActive
SureFISH PAX3 3' BA 575Kb P20 GR G110206G
FDA UDI
Class IActive
SureFISH MALT1 BA P200 G111927
FDA UDI
Class IActive
SureFISH 7q31.2 MET 400kb P5RDx6 G210900R
FDA UDI
Class IUnknown
SureFISH Chr22 CEP 668kb P20 GR G110888G
FDA UDI
Class IActive
SureFISH MYC BA P200 G111923
FDA UDI
Class IActive
SureFISH 21q22.2 ERG 5p BA 552kb P5GR G110916G
FDA UDI
Class IUnknown
SureFISH Chr7 CEP 767kb P20 GR G110899G
FDA UDI
Class IActive
406psub1-Si 406PSUB1-SI
FDA UDI
Class IActive
SureFISH Chr17 CEP 436kb P20 GR G110993G
FDA UDI
Class IActive
SureFISH 9p21.3 CDKN2A 188kb P20 RD G110350R
FDA UDI
Class IActive
405tsus-Si 405TSUS-SI
FDA UDI
Class IActive
SureFISH Chr18 CEP 711kb P20 RD G110271R
FDA UDI
Class IActive
SureFISH 2p21 EML4 496kb P5 RD6 G210920R
FDA UDI
Class IUnknown
Bstckn2-Si BSTCKN2-SI
FDA UDI
Class IActive
SureFISH 17q25.3 Chr17qTel 405kb P20 RD G110311R
FDA UDI
Class IUnknown
SureFISH 17q21.33 COL1A1 DF 789kb P20 RD G110733R
FDA UDI
Class IActive
SureFISH 9q34.11 ABL1 5' BA 350kb P20 RD G110419R
FDA UDI
Class IActive
SureFISH 8q24.21 MYC 3' TC 398kb P20 BL G110830B
FDA UDI
Class IUnknown
Dako IC001
FDA UDI
Class IActive
SureFISH 3q27.3 BCL6 DF 785kb P20 GR G110462G
FDA UDI
Class IActive
SureFISH CCND1 DF 577kb P20GRX5 G210976G
FDA UDI
Class IUnknown
SureFISH Chr12 CEP 704kb P20 BL G110890B
FDA UDI
Class IActive
SureFISH ALK BA P5 G111200
FDA UDI
Class IUnknown
SureFISH 8p23.1 GATA4 118kb P20 RD G110749R
FDA UDI
Class IUnknown
SureFISH ROS1-GOPC 5' BA 245kb P100 RD G110136R
FDA UDI
Class IActive
SureFISH 4q12 CHIC2 469kb P20 RD G110305R
FDA UDI
Class IActive
SureFISH 12p13.33 Chr12pTel 407kb P20 RD G110335R
FDA UDI
Class IUnknown
SureFISH 7q31.2 D7S486 200kb P20 RD G110246R
FDA UDI
Class IActive
Mono Rb A-Hu Cytokeratin 8/18 Cl EP17/30 M3652
FDA UDI
Class IUnknown
SureFISH 4q35.2 Chr4qTel 408kb P20 RD G110349R
FDA UDI
Class IUnknown
SureFISH 7p21.1 AHR 150kb P20 RD G110403R
FDA UDI
Class IActive
Mono Mo A-Hu MutL Protein Homolog 1 Cl ES05 M3640
FDA UDI
Class IActive
Mono Mo A-Hu Progesterone Receptor, Cl PgR 636 M3569
FDA UDI
Class IIUnknown
FLEX Mono Mo A-Hu Prostate-Specific Membrane Antigen Cl 3E6 RTU (Link) IR089
FDA UDI
Class IActive
SureFISH 1q23.1 PRCC 451kb P20 GR G110436G
FDA UDI
Class IActive
SureFISH 20q13.2 ZNF217 480kb P20 GR G110440G
FDA UDI
Class IActive
SureFISH 1q23.1 NTRK1 5' BA 182kb P20 GR G110430G
FDA UDI
Class IActive
SureFISH 22q12.2 EWSR1 DF 740kb P20 GR G110463G
FDA UDI
Class IActive
FLEX Mono Mo A-Thyroid Transcription Factor, TTF-1 Cl 8G7G3/1 RTU (Link) IR056
FDA UDI
Class IActive
SureFISH Chr12 CEP 704kb P20 GR G110890G
FDA UDI
Class IActive
SureFISH 7q34 BRAF 227kb P20 RD G110258R
FDA UDI
Class IActive
Cyt5mfav-Si CYT5MFAV-SI
FDA UDI
Class IActive
C10mpwc-Si C10MPWC-SI
FDA UDI
Class IActive
SureFISH 10q26 FGFR2 360kb P20RD G110981R
FDA UDI
Class IActive
Lfxw-Si LFXW-SI
FDA UDI
Class IActive
SureFISH 1p13.2 NRAS 310kb P5RD G110912R
FDA UDI
Class IActive
Lambda mRNA CISH Probe G111920
FDA UDI
Class IActive
N2s-Si N2S-SI
FDA UDI
Class IActive

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