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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 11 of 24
DeviceModel / ReferenceRegistriesClassStatus
SureFISH 16q22.1 CBFB 3' BA 284kb P20 GR G110245G
FDA UDI
Class IActive
SureFISH 9p23 NFIB DF 500kb P20 GR G110466G
FDA UDI
Class IActive
SureFISH 15q12 GABRB3 230kb P20 RD G110298R
FDA UDI
Class IUnknown
SureFISH 17q21.31 MAPT 373kb P20 GR G110748G
FDA UDI
Class IActive
User-Fillable Reagent Bottle 25mL Capacity (Link) SK202
FDA UDI
Class IActive
405lsusq-Si 405LSUSQ-SI
FDA UDI
Class IActive
FLEX Mono Mo A-Hu E-Cadherin Cl NCH-38 RTU (Dako Omnis) GA059
FDA UDI
Class IActive
SureFISH 5q35.1 TLX3 3' BA 416kb P20 GR G110369G
FDA UDI
Class IActive
Cyt5f-Si CYT5F-SI
FDA UDI
Class IActive
50ts12-Si 50TS12-SI
FDA UDI
Class IActive
Cyt5fv-Si CYT5FV-SI
FDA UDI
Class IActive
SureFISH FOXO1 3' BA 600kb P100 GR G110116G
FDA UDI
Class IActive
SureFISH 6q23.3 MYB 5' BA 400kb P100 RD G110150R
FDA UDI
Class IActive
SureFISH 8q24.21 MYC 3' BA 432kb P20 RD G110395R
FDA UDI
Class IUnknown
MSH6 IHC pharmDx (Dako Omnis) GE086
FDA UDI
Class IIIActive
SureFISH 7q34 BRAF 5' BA 510kb P20 GR G110400G
FDA UDI
Class IActive
SureFISH 8q13.3 NCOA2 5' BA 258kb P20 RD G110222R
FDA UDI
Class IUnknown
Mono Mo A-Hu MutS Protein Homolog 2 Cl FE11 M3639
FDA UDI
Class IActive
SureFISH 10p15.3 Chr10pTel 372kb P20 RD G110331R
FDA UDI
Class IUnknown
SureFISH 19q13.31 BCL3 5' BA 305kb 20 RD G110289R
FDA UDI
Class IActive
SureFISH TFE3 5' BA 237kb P5GR G110906G
FDA UDI
Class IUnknown
SureFISH 1q23.3 PBX1 DF 603kb P20 RD G110292R
FDA UDI
Class IActive
SureFISH 22q11.23 BCR DF 1388kb P20 GR G110455G
FDA UDI
Class IActive
406fx-Si 406FX-SI
FDA UDI
Class IActive
Malt1 Ba P20 G111420
FDA UDI
Class IActive
SureFISH 18q21.33 BCL2 3’ BA 389kb P20 RD5 G210988R
FDA UDI
Class IUnknown
Artisan Alpha Amylase AR171
FDA UDI
Class IActive
Mono Mo A-Hu E-cadherin Cl NCH-38 M3612
FDA UDI
Class IActive
Dako IS074
FDA UDI
Class IUnknown
SureFISH Xp22/Yp11 CRLF2 5' BA P20GRX5 G210980G
FDA UDI
Class IUnknown
N2t-Si N2T-SI
FDA UDI
Class IActive
SureFISH 17p11.2 RAI1 263kb P20 RD G110384R
FDA UDI
Class IActive
SureFISH 17q12 HER2 191kb P20GR G110969G
FDA UDI
Class IActive
SureFISH ALK 5'BA 599kb P20 GR G110992G
FDA UDI
Class IUnknown
FLEX Mono Mo A-Hu Wilms’ Tumor 1 (WT1) Protein Cl 6F-H2 RTU IS055
FDA UDI
Class IUnknown
SureFISH 1p36 MORN1-TNFRSF14 297kb 20 RD G110753R
FDA UDI
Class IActive
SureFISH 10q26.13 FGFR2 5' BA 400kb RD G110725R
FDA UDI
Class IActive
SureFISH 9p24.3 Chr9pTel 428kb P20 GR G110898G
FDA UDI
Class IUnknown
N2mon-Si N2MON-SI
FDA UDI
Class IActive
405lsuvs-Si 405LSUVS-SI
FDA UDI
Class IActive
EGFR pharmDx™ for Autostainer K1494
FDA UDI
Class IIIUnknown
SureFISH 10q26.12 FGFR2 3' BA 400kb GR G110726G
FDA UDI
Class IActive
SureFISH 8p23.3 Chr8pTel 406kb P20 GR G110896G
FDA UDI
Class IUnknown
SureFISH MLL 3' BA 199kb P20 RD G110253R
FDA UDI
Class IActive
SureFISH 2p24.3 MYCN 277kb P20 RD G110751R
FDA UDI
Class IActive
FLEX Negative Control Rb Immunoglobulin RTU IS600
FDA UDI
Class IUnknown
406psu0sb-Si 406PSU0SB-SI
FDA UDI
Class IActive
SureFISH TCRAD 3' BA 305kb P20 RD G110363R
FDA UDI
Class IActive
SureFISH Chr1 CEP 541kb P20 BL G110864B
FDA UDI
Class IActive
SureFISH FOXO1 3' BA 600kb P20 GR G110986G
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