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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 21 of 24
DeviceModel / ReferenceRegistriesClassStatus
SureFISH 16p11.2 FUS 3' BA 365kb GR G110930G
FDA UDI
Class IUnknown
SureFISH 19p13.2 ZNF443 513kb P20 BL G110735B
FDA UDI
Class IActive
SureFISH 19p13.2 ZNF443 513kb P100 GR G110101G
FDA UDI
Class IActive
FLEX Mono Mo A-Hu CDX2 Cl DAK-CDX2 RTU (Dako Omnis) GA080
FDA UDI
Class IActive
SureFISH Chr17 CEP 436kb P20 GR5 G210993G
FDA UDI
Class IUnknown
SureFISH Chr2 CEP 448kb P20 GR G110889G
FDA UDI
Class IActive
SureFISH 17p13.1 TP53 247kb P20 BL G110428B
FDA UDI
Class IActive
SureFISH Chr7 CEP P5GR G110902G
FDA UDI
Class IUnknown
Slxfats-Si SLXFATS-SI
FDA UDI
Class IActive
SureFISH 7p22.3 Chr7pTel 426kb P20 GR G110895G
FDA UDI
Class IUnknown
SureFISH 10q11.21 RET 3' BA 623kb P20 GR G110985G
FDA UDI
Class IUnknown
SureFISH 9p24.3 Chr9pTel 428kb P20 RD G110358R
FDA UDI
Class IUnknown
N2sa-Si N2SA-SI
FDA UDI
Class IActive
SureFISH 5q31.2 EGR1 184kb P20 RD G110249R
FDA UDI
Class IActive
N2abt-Si N2ABT-SI
FDA UDI
Class IActive
SureFISH 10q11 RET 3' BA 623kb P20 GR5 G210985G
FDA UDI
Class IUnknown
ELx808AESKU ELx808AESKU
FDA UDI
Class IActive
SureFISH 12p12.1 KRAS 354kb P20 RD G110372R
FDA UDI
Class IActive
SureFISH 6q21 SEC63 241kb P20 GR G110449G
FDA UDI
Class IActive
SureFISH 17q12 HER2 191kb P100 GR G110139G
FDA UDI
Class IActive
SureFISH ChrX CEP 587kb P20 GR G110862G
FDA UDI
Class IActive
FLEX Mono Mo A-Hu MutL Protein Homolog 1 Cl ES05 RTU IS079
FDA UDI
Class IUnknown
SureFISH 5q32 PDGFRB 3’ BA 354kb P20 RD G110303R
FDA UDI
Class IActive
SureFISH 22q12.2 NF2 119kb P20 GR G110756G
FDA UDI
Class IActive
SureFISH 18q21 BCL2 3' BA 624kb P5 RD6 G210938R
FDA UDI
Class IUnknown
ELx405C-SI ELx405C-SI
FDA UDI
Class IActive
SureFISH 3q29 Chr3qTel 380kb P20 GR G110853G
FDA UDI
Class IUnknown
SureFISH 22q13.33 Chr22qTel 383kb P20 GR G110850G
FDA UDI
Class IUnknown
SureFISH 10q11.21 RET 5' BA 439kb P5 RD G110934R
FDA UDI
Class IUnknown
SureFISH 17q21.2 TOP2A 327kb P20 RD G110308R
FDA UDI
Class IActive
FLEX Mono Mo A-Hu Cytokeratin Cl AE1/AE3 RTU (Dako Omnis) GA053
FDA UDI
Class IActive
SureFISH 1q21.2 BCL9 99kb P20 RD G110351R
FDA UDI
Class IUnknown
SureFISH 17p12 PMP22 458kb P20 BL G110879B
FDA UDI
Class IActive
SureFISH 21q22.2 ERG 5p BA 552kb P5GRx6 G210916G
FDA UDI
Class IUnknown
SureFISH 17q12 HER2 191kb P5 RD G110909R
FDA UDI
Class IUnknown
SureFISH 20q13.2 ZNF217 480kb P20GO G110971Y
FDA UDI
Class IUnknown
405tshtv-Si 405TSHTV-SI
FDA UDI
Class IActive
Mono Mo A-Hu Cytokeratin Cls AE1/AE3 M3515
FDA UDI
Class IActive
405lsus-Si 405LSUS-SI
FDA UDI
Class IActive
Cyt5mfaw-Si CYT5MFAW-SI
FDA UDI
Class IActive
SureFISH ALK BA P20X6 G211400
FDA UDI
Class IUnknown
SureFISH 10q26 FGFR2 360kb P5 RD6 G210918R
FDA UDI
Class IUnknown
FLEX Mono Rb A-Hu Postmeiotic Segregation Increased 2 Cl EP51 RTU (Link) IR087
FDA UDI
Class IActive
50ts8f-Si 50TS8F-SI
FDA UDI
Class IActive
SureFISH TGFBR3 3' BA 402kb P20 RD G110207R
FDA UDI
Class IActive
SureFISH 2p11.2 IGK DF 1966kb P20 GR G110415G
FDA UDI
Class IActive
FLEX Mono Mo A-Hu Smooth Muscle Myosin Heavy Chain Cl SMMS-1 RTU (Link) IR066
FDA UDI
Class IActive
FLEX Mono Mo A-Hu Melanosome Cl HMB45 RTU IS052
FDA UDI
Class IUnknown
SureFISH 7p14.1 TRG 5' BA 586kb P20 GR G110703G
FDA UDI
Class IActive
SureFISH ALK BA P20 G111400
FDA UDI
Class IActive

Related Companies

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Importers

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Notified Bodies

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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