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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 13 of 24
DeviceModel / ReferenceRegistriesClassStatus
SureFISH Chr15 CEP 265kb P20 BL G110872B
FDA UDI
Class IActive
SureFISH FOXO1 3' BA 600kb P5 RD G110904R
FDA UDI
Class IUnknown
SureFISH 12q13.3 DDIT3 3' BA 537kb P5 GR G110922G
FDA UDI
Class IUnknown
SureFISH Chr7 CEP 767kb P100 GR G110119G
FDA UDI
Class IActive
SureFISH 13q12.2 FLT3 5’ BA 496kb P20 GR G110326G
FDA UDI
Class IActive
SureFISH 4q12 FIP1L1 TC 500kb P20 GR G110439G
FDA UDI
Class IActive
SureFISH 12q14 DDIT3 5' BA 498kb P20RDX5 G210983R
FDA UDI
Class IUnknown
SureFISH 16p13.3 Chr16pTel 428kb P20 BL G110876B
FDA UDI
Class IUnknown
SureFISH Xq13.2 XIST 161kb P20 RD G110296R
FDA UDI
Class IUnknown
SureFISH 10p11.22 KIF5B DF 788kb GR G110932G
FDA UDI
Class IUnknown
SureFISH 11p15.5 Chr11pTel 408kb P20 BL G110840B
FDA UDI
Class IUnknown
SureFISH 15q25.3 NTRK3 5' BA 481kb GR G110723G
FDA UDI
Class IActive
SureFISH Chr21 CEP 653kb P20 GR G110887G
FDA UDI
Class IActive
SureFISH 3p25.2 PPARG DF 326kb P20 GR G110468G
FDA UDI
Class IActive
SureFISH 2p21 EML4 496kb P5 GR G110920G
FDA UDI
Class IUnknown
FLEX Mono Mo A-Hu CD15 Cl Carb-3 RTU (Link) IR062
FDA UDI
Class IActive
SureFISH 15q13.3 CHRNA7 123kb P20 RD G110743R
FDA UDI
Class IUnknown
SARS-CoV-2 IgG ELISA Kit K1919
FDA UDI
NActive
SureFISH FOXO1 3' BA 600kb P5 RD6 G210904R
FDA UDI
Class IUnknown
FLEX Mono Mo A-Hu Podoplanin Cl D2-40 RTU (Link) IR072
FDA UDI
Class IActive
SureFISH MLL 5' BA 497kb P20 GR G110254G
FDA UDI
Class IActive
SureFISH 18q21.33 BCL2 5’ BA 598kb P5GR6 G210925G
FDA UDI
Class IUnknown
ELx405CVS-SI ELx405CVS-SI
FDA UDI
Class IActive
SureFISH 12q14.1 CDK4 308kb P100 RD G110145R
FDA UDI
Class IActive
SureFISH Chr10 CEP 676kb P20 RD G110276R
FDA UDI
Class IActive
SureFISH 18q21 BCL2 5' BA 598kb P5 GR6 G210937G
FDA UDI
Class IUnknown
405lsu-Si 405LSU-SI
FDA UDI
Class IActive
SureFISH 1p12 NOTCH2 81kb P20 RD G110371R
FDA UDI
Class IActive
SureFISH 8q12.1 PLAG1 3' BA 295kb P20 RD G110226R
FDA UDI
Class IActive
SureFISH 12q24.33 Chr12qTel 424kb P20 RD G110336R
FDA UDI
Class IUnknown
SureFISH 11q22.3 ATM 732kb P20 GR G110360G
FDA UDI
Class IActive
SureFISH 19q13.33 GLTSCR2 298kb P100 RD G110103R
FDA UDI
Class IActive
SureFISH 13q14.2 D13S319 154kb P20 RD G110252R
FDA UDI
Class IActive
SureFISH 18q21.33 BCL2 5’ BA 598kb P20 GR G110989G
FDA UDI
Class IUnknown
SureFISH EWSR1 5' BA 564kb P20 GR G110456G
FDA UDI
Class IActive
Cyt5mf-Si CYT5MF-SI
FDA UDI
Class IActive
50ts8mf-Si 50TS8MF-SI
FDA UDI
Class IActive
SureFISH NUP214 5’ BA 548kb P20 GR G110323G
FDA UDI
Class IUnknown
Mono Mo A-Hu E-cadherin Cl NCH-38 M3612
FDA UDI
Class IActive
SureFISH 16p11.2 FUS 3' BA 365kb GR6 G210930G
FDA UDI
Class IUnknown
Mono Rb A-Hu AMACR Cl 13H4 M3616
FDA UDI
Class IActive
Mono Mo A-Thyroid Transcription Factor (TTF-1) Cl 8G7G3/1 M3575
FDA UDI
Class IActive
N2ma-Si N2MA-SI
FDA UDI
Class IActive
SureFISH 3q27.3 BCL6 3’ BA 371kb P5 RD6 G210926R
FDA UDI
Class IUnknown
Mono Mo A-Hu MutL Protein Homolog 1 Cl ES05 M3640
FDA UDI
Class IActive
SureFISH 3q28 TP63 5' BA 372kb P20 RD G110714R
FDA UDI
Class IActive
Llx-Si LLX-SI
FDA UDI
Class IActive
SureFISH 8q12.1 PLAG1 3' BA 400kb 100 RD G110152R
FDA UDI
Class IActive
Mono Mo A-Hu Thyroid Stimulating Hormone (TSH) Cl 0042 M3503
FDA UDI
Class IUnknown
FLEX Mono Mo A-Myogenin Cl F5D RTU (Link) IR067
FDA UDI
Class IActive

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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