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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 16 of 24
DeviceModel / ReferenceRegistriesClassStatus
SureFISH 8q24.3 Chr8qTel 397kb P20 RD G110357R
FDA UDI
Class IUnknown
SureFISH FOXO1 5' BA 601kb P5 GR6 G210905G
FDA UDI
Class IUnknown
Mono Mo A-Hu Progesterone Receptor, Cl PgR 636 M3569
FDA UDI
Class IIActive
SureFISH 12p13.2 ETV6 505kb P20 RD G110229R
FDA UDI
Class IActive
SureFISH 3q26.2 MECOM 5' BA 408kb P20 RD G110361R
FDA UDI
Class IActive
SureFISH FOXO1 5' BA 601kb P5 RD6 G210905R
FDA UDI
Class IUnknown
Mono Mo A-Hu PD-L1, Clone 22C3 M3653
FDA UDI
Class IActive
SureFISH 19q13.43 Chr19qTel 405kb P20 BL G110847B
FDA UDI
Class IUnknown
Mono Mo A-Hu Beta-Catenin Cl ß-Catenin-1 M3539
FDA UDI
Class IUnknown
SureFISH 3p26.3 Chr3pTel 381kb P20 GR G110860G
FDA UDI
Class IUnknown
ELx808-SI ELx808-SI
FDA UDI
Class IActive
SureFISH 12p13.33 Chr12pTel 407kb P20 GR G110836G
FDA UDI
Class IUnknown
Mono Mo A-Hu CA 19-9 Cl 1116-NS-19-9 M3517
FDA UDI
Class IActive
406psub1sb-Si 406PSUB1SB-SI
FDA UDI
Class IActive
N2smb-Si N2SMB-SI
FDA UDI
Class IActive
Mono Mo A-Hu Prostate-Specific Membrane Antigen Cl 3E6 M3620
FDA UDI
Class IUnknown
Cyt5faw-Si CYT5FAW-SI
FDA UDI
Class IActive
SureFISH MGEA5 5' BA 353kb P20 RD G110209R
FDA UDI
Class IActive
SureFISH 4p16.3 FGFR3 DF 623kb P20 RD G110301R
FDA UDI
Class IActive
SureFISH 11q13.3 CCND1 997kb P20 RD G110212R
FDA UDI
Class IActive
FLEX Mono Mo A-Hu Renal Cell Carcinoma Marker, Cl SPM314, RTU (Dako Omnis) GA075
FDA UDI
Class IActive
FLEX Mono Rb A-Hu AMACR Cl 13H4 RTU (Link) IR060
FDA UDI
Class IActive
405lshtv-Si 405LSHTV-SI
FDA UDI
Class IActive
SureFISH 14q32.33 IGH DF 1519kb P100 GR G110147G
FDA UDI
Class IActive
SureFISH 6p21.1 TFEB 5' BA 288kb P20 RD G110242R
FDA UDI
Class IActive
N2m-Si N2M-SI
FDA UDI
Class IActive
SureFISH 6q23.3 MYB DF 500kb P20 RD G110465R
FDA UDI
Class IActive
SureFISH EWSR1 3' BA 263kb P100 RD G110106R
FDA UDI
Class IActive
SureFISH FOXO1 3' BA 600kb P5 GR G110904G
FDA UDI
Class IUnknown
SureFISH 15q22.31 SMAD6 182kb P20 GR G110758G
FDA UDI
Class IUnknown
SureFISH 9q34.3 Chr9qTel 429kb P20 BL G110861B
FDA UDI
Class IUnknown
SureFISH 12q14.1 CDK4 308kb P5GRx6 G210911G
FDA UDI
Class IUnknown
405lsht-Si 405LSHT-SI
FDA UDI
Class IActive
SureFISH 19q13.33 GLTSCR2 298kb P20 RD G110386R
FDA UDI
Class IActive
SureFISH 7q36.3 Ch7qTel 396kb P20 GR G110854G
FDA UDI
Class IUnknown
SureFISH 1q25.2 ABL2 600kb P100 GR G110100G
FDA UDI
Class IActive
SureFISH 11p11.2 EXT2 56kb P20 RD G110330R
FDA UDI
Class IUnknown
SureFISH 5p15.33 Chr5pTel 403kb P20 RD G110352R
FDA UDI
Class IUnknown
SureFISH Xp22.31 KAL1 186kb P20 RD G110299R
FDA UDI
Class IUnknown
MMR Negative Control Reagent, Mouse (Dako Omnis) GE101
FDA UDI
Class IIIActive
FLEX Mono Mo A-Hu Cytokeratin HMW High Molecular Weight Cl 34ßE12 RTU IS051
FDA UDI
Class IUnknown
SureFISH 4p16.3 FGFR3 405kb P5 GR G110917G
FDA UDI
Class IUnknown
SureFISH RET BA P20X6 G211402
FDA UDI
Class IUnknown
SureFISH 9q34.11 ASS1 367kb P20 BL G110833B
FDA UDI
Class IActive
Ki-67 IHC MIB-1 pharmDx (Dako Omnis) GE020
FDA UDI
Class IIIActive
FLEX Mono Mo A-Hu E-Cadherin Cl NCH-38 RTU (Link) IR059
FDA UDI
Class IActive
PD-L1 IHC 22C3 pharmDx SK006
FDA UDI
Class IIIActive
SureFISH 10q26 FGFR2 360kb P5 RD G110918R
FDA UDI
Class IUnknown
SureFISH 22q11.22 IGL 3' BA 343kb P20 RD G110730R
FDA UDI
Class IActive
SureFISH 6p25.3 DUSP22-IRF4 3' 235kb GR G110713G
FDA UDI
Class IActive

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