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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 5 of 24
DeviceModel / ReferenceRegistriesClassStatus
SureFISH 21q22.13 ERG DF 777kb P5RD G110913R
FDA UDI
Class IUnknown
405tsuvs-Si 405TSUVS-SI
FDA UDI
Class IActive
SureFISH 21q22.13 ERG 3p BA 426kb P5RD G110915R
FDA UDI
Class IUnknown
SureFISH Chr8 CEP 635kb P20 BL G110834B
FDA UDI
Class IActive
SureFISH 18q23 Chr18qTel 413kb P20 BL G110845B
FDA UDI
Class IUnknown
SureFISH 13q34 Chr13qTel 357kb P20 BL G110841B
FDA UDI
Class IUnknown
SureFISH 12q14.1 CDK4 308kb P5RDx6 G210911R
FDA UDI
Class IUnknown
SureFISH 2q13 NPHP1 124kb P20 RD G110742R
FDA UDI
Class IActive
SureFISH 20q13.2 ZNF217 480kb P20GO G210971Y
FDA UDI
Class IUnknown
SureFISH 11q21 MAML2 DF 496kb P20 RD G110478R
FDA UDI
Class IActive
FLEX Poly Guinea Pig A-Insulin RTU (Link) IR002
FDA UDI
Class IActive
SureFISH 7q36.3 Chr7qTel 396kb P20 RD G110320R
FDA UDI
Class IUnknown
SureFISH 2p14 MEIS1 5' BA 300kb P20 GR G110237G
FDA UDI
Class IActive
SureFISH 5p15.31 D5S630 370kb P20 GR G110437G
FDA UDI
Class IActive
Mono Mo A-Hu CD15 Cl Carb-3 M3631
FDA UDI
Class IActive
SureFISH 8q21.13 HEY1 DF 774kb P20 GR G110288G
FDA UDI
Class IActive
Dako M3561
FDA UDI
Class IActive
Cyt5mpw-Si CYT5MPW-SI
FDA UDI
Class IActive
SureFISH 8q24.21 MYC DF 815kb P20 RD G110396R
FDA UDI
Class IActive
FLEX Negative Control Rb Immunoglobulin RTU (Link) IR600
FDA UDI
Class IActive
SureFISH 5q32 PDGFRB 5’ BA 435kb P20 GR G110304G
FDA UDI
Class IActive
SureFISH Xp11.23 TFE3 523kb P20 RD G110241R
FDA UDI
Class IActive
SureFISH Chr4 CEP 613kb P20 BL G110866B
FDA UDI
Class IActive
SureFISH 13q14.2 RB1 522kb P20 GR G110284G
FDA UDI
Class IUnknown
Mono Mo A-Hu Survivin Cl 12C4 M3624
FDA UDI
Class IUnknown
SureFISH ALK 3' BA 300kb P5GRx6 G210908G
FDA UDI
Class IUnknown
SureFISH 11q25 Chr11qTel 398kb P20 RD G110334R
FDA UDI
Class IActive
SureFISH 20q13.33 Chr20qTel 379kb P20 RD G110317R
FDA UDI
Class IUnknown
SureFISH 1q21.3 CKS1B 386kb P20 RD G110324R
FDA UDI
Class IActive
405tsuvsq-Si 405TSUVSQ-SI
FDA UDI
Class IActive
SureFISH 18q21.33 BCL2 3’ BA 389kb P5 GR G110924G
FDA UDI
Class IUnknown
SureFISH 11p15.4 NUP98 3' 359kb P20 RD G110718R
FDA UDI
Class IActive
FLEX Mono Mo A-Hu Wilms’ Tumor 1 (WT1) Protein Cl 6F-H2 RTU (Link) IR055
FDA UDI
Class IActive
SureFISH 18p11.32 Chr18pTel 403kb P20 GR G110844G
FDA UDI
Class IUnknown
SureFISH FOXO1 3' BA 600kb P5 GR6 G210904G
FDA UDI
Class IUnknown
SureFISH 15q26.3 Chr15qTel 391kb P20 RD G110329R
FDA UDI
Class IUnknown
SureFISH 3q27.3 BCL6 3’ BA 371kb P5 RD G110926R
FDA UDI
Class IUnknown
FLEX Mono Mo A-Villin Cl 1D2 C3 RTU (Link) IR076
FDA UDI
Class IActive
SureFISH Chr9 CEP 367kb P20GR G110975G
FDA UDI
Class IActive
SureFISH 20p13 Chr20pTel 386kb P20 GR G110848G
FDA UDI
Class IUnknown
SureFISH 12p13.2 ETV6 3' BA 384kb P20 RD G110273R
FDA UDI
Class IActive
SureFISH Chr22 CEP 668kb P20 BL G110888B
FDA UDI
Class IActive
Ccnd1 Ba P20 G111443
FDA UDI
Class IActive
Mfp-Si MFP-SI
FDA UDI
Class IActive
SureFISH 7p12.2 IKZF1 128kb P20 RD G110398R
FDA UDI
Class IActive
Mono Mo A-Hu CD5 Cl 4C7 M3641
FDA UDI
Class IUnknown
SureFISH 8q12.1 PLAG1 5' BA 625kb P20 GR G110227G
FDA UDI
Class IActive
SureFISH 15q26.3 Chr15qTel 391kb P20 BL G110855B
FDA UDI
Class IUnknown
SureFISH Chr19 CEP 527kb P20 RD G110272R
FDA UDI
Class IActive
SureFISH 12q14.1 DDIT3 5'BA 498kb P5 RD6 G210923R
FDA UDI
Class IUnknown

Related Companies

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No authorised representatives on record.

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