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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 7 of 24
DeviceModel / ReferenceRegistriesClassStatus
Cyt5mfa-Si CYT5MFA-SI
FDA UDI
Class IActive
SureFISH 21q22.13 ERG DF 777kb P5GR G110913G
FDA UDI
Class IUnknown
EBER RNA CISH Probe G111921
FDA UDI
Class IActive
SureFISH 6p25.3 Chr6pTel 423kb P20 GR G110839G
FDA UDI
Class IUnknown
405tsht-Si 405TSHT-SI
FDA UDI
Class IActive
SureFISH 8q24.21 MYC DF 815kb P20BL G110970B
FDA UDI
Class IActive
SureFISH 22q13.33 Chr22qTel 383kb P20 BL G110850B
FDA UDI
Class IUnknown
SureFISH 10p11.22 KIF5B DF 788kb RD6 G210932R
FDA UDI
Class IUnknown
SureFISH PDGFD BA 3’ BA 350kb P20 RD G110406R
FDA UDI
Class IActive
FLEX Mono Rb A-Hu Terminal Deoxynucleotidyl Transferase Cl EP266 RTU (Link) IR093
FDA UDI
Class IActive
SureFISH 16p11.2 FUS 3' BA 365kb RD G110930R
FDA UDI
Class IUnknown
Cyt1fav-Si CYT1FAV-SI
FDA UDI
Class IActive
Cyt5fw-Si CYT5FW-SI
FDA UDI
Class IActive
SureFISH Chr17 CEP 436kb P20BL G210972B
FDA UDI
Class IUnknown
SureFISH 12q14 DDIT3 5' BA 498kb P100 RD G110115R
FDA UDI
Class IActive
SureFISH Chr11 CEP 798kb P20 BL G110883B
FDA UDI
Class IActive
SureFISH 8q24.21 MYC DF 815kb P20BL G210970B
FDA UDI
Class IUnknown
SureFISH 2p23.2 ALK 479kb P5 GR6 G210919G
FDA UDI
Class IUnknown
FLEX Mono Mo A-Hu Melanosome Cl HMB-45 RTU (Dako Omnis) GA052
FDA UDI
Class IActive
SureFISH 7p11.2 EGFR 188kb P20 RD G110321R
FDA UDI
Class IActive
SureFISH PDGFB 3' BA 362kb P20 RD G110405R
FDA UDI
Class IActive
Mono Mo A-Hu Laminin Cl 4C7 M0638
FDA UDI
Class IUnknown
FLEX Mono Mo A-Hu Cytokeratin HMW High Molecular Weight Cl 34ßE12 RTU (Link) IR051
FDA UDI
Class IActive
SureFISH 18q21 BCL2 5' BA 598kb P5 RD6 G210937R
FDA UDI
Class IUnknown
Mono Mo A-Hu Follicle Stimulating Hormone (FSH) Cl C10 M3504
FDA UDI
Class IUnknown
SureFISH Chr9 CEP 367kb P100 GR G110144G
FDA UDI
Class IActive
SureFISH 20p11.21 NINL 369kb P20 RD G110306R
FDA UDI
Class IUnknown
Dako GC201
EUDAMEDFDA UDI
Class IActive
SureFISH 6q27 Chr6qTel 390kb P20 RD G110354R
FDA UDI
Class IUnknown
SureFISH 12q14.1 CDK4 308kb P5GR G110911G
FDA UDI
Class IActive
406psub2-Si 406PSUB2-SI
FDA UDI
Class IActive
SureFISH 2q37.3 Chr2qTel 415kb P20 RD G110346R
FDA UDI
Class IUnknown
SureFISH 18q23 Chr18qTel 413kb P20 GR G110845G
FDA UDI
Class IUnknown
Mono Mo A-Hu Podoplanin Cl D2-40 M3619
FDA UDI
Class IActive
FLEX Mono Mo A-Hu Inhibin a Cl R1 RTU (Dako Omnis) GA058
FDA UDI
Class IActive
SureFISH Chr19 CEP 527kb P20 GR G110875G
FDA UDI
Class IActive
406sna0lb-Si 406SNA0LB-SI
FDA UDI
Class IActive
SureFISH 18q11.2 SS18 3’ BA 616kb P20 GR G110457G
FDA UDI
Class IActive
Dako IS077
FDA UDI
Class IUnknown
406pub1-Si 406PUB1-SI
FDA UDI
Class IActive
SureFISH 4p16.3 Chr4pTel 403kb P20 GR G110348G
FDA UDI
Class IUnknown
SureFISH 10q24.32 MGEA5 3' BA 743kb GR G110429G
FDA UDI
Class IActive
Dako K1906
FDA UDI
Class IIIUnknown
SureFISH 19p13.3 Chr19pTel 409kb P20 RD G110314R
FDA UDI
Class IUnknown
SureFISH 19p13.2 EPOR 3' BA 299kb P20 RD G110412R
FDA UDI
Class IActive
SureFISH YWHAE 3' BA 608kb P20 GR G110225G
FDA UDI
Class IActive
SureFISH 10q26.3 Chr10qTel 391kb P20 RD G110332R
FDA UDI
Class IUnknown
SureFISH FOXO1 5' BA 601kb P20 RD G110987R
FDA UDI
Class IActive
SureFISH 9q21.33 NTRK2 5' BA 406kb GR G110721G
FDA UDI
Class IActive
PD-L1 Control Slides T1391
EUDAMEDFDA 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