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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
LinkedIn
—
Facebook
—
Phone
+45 44859756
PRRC Contact
Grace Lee
EUDAMED SRN
US-MF-000009385
FDA FEI Number
3009189893
DUNS Number
—

Catalogue (1184)

Page 22 of 24
DeviceModel / ReferenceRegistriesClassStatus
Lp580-Si LP580-SI
FDA UDI
Class IActive
Cyt5fa-Si CYT5FA-SI
FDA UDI
Class IActive
SureFISH Chr3 CEP 592kb P20 RD G110262R
FDA UDI
Class IActive
SureFISH 2p14 MEIS1 3' BA 300kb P20 RD G110236R
FDA UDI
Class IActive
SureFISH 13q12.2 FLT3 3’ BA 428kb P20 RD G110325R
FDA UDI
Class IActive
SureFISH 12q14.1 DDIT3 5'BA 498kb P5 GR6 G210923G
FDA UDI
Class IUnknown
SureFISH 6p25.1 RREB1 638kb P20 RD G110401R
FDA UDI
Class IActive
SureFISH 18p11.32 Chr18pTel 403kb P20 RD G110312R
FDA UDI
Class IUnknown
SureFISH 14q32.33 Chr14qTel 415kb P20 BL G110851B
FDA UDI
Class IUnknown
SureFISH Chr5 CEP 633kb P20 GR G110867G
FDA UDI
Class IActive
SureFISH 16q24.3 Chr16qTel 424kb P20 BL G110877B
FDA UDI
Class IUnknown
FLEX Mono Rb A-Hu Estrogen Receptor a Clone EP1 RTU (Link) IR084
FDA UDI
Class IIActive
SureFISH PAX3 5' BA 285Kb P20 RD G110205R
FDA UDI
Class IActive
SureFISH JAK2 5' BA 286kb P20 RD G110200R
FDA UDI
Class IActive
SureFISH 1p33 SIL 3’ BA 566kb P20 GR G110707G
FDA UDI
Class IActive
SureFISH 14q32.13 TCL1 5' BA 361kb RD G110708R
FDA UDI
Class IActive
SureFISH 21q22.3 TMPRSS2 DF 873kb P5RD G110914R
FDA UDI
Class IUnknown
SureFISH 8q24.21 MYC 294kb P20 RD G110365R
FDA UDI
Class IActive
Poly Rb A-Hu Growth Hormone A0570
FDA UDI
Class IActive
405tsrvs-Si 405TSRVS-SI
FDA UDI
Class IActive
406psub3sb-Si 406PSUB3SB-SI
FDA UDI
Class IActive
SureFISH 4p16.3 FGFR3 405kb P5 RD G110917R
FDA UDI
Class IUnknown
405lsr-Si 405LSR-SI
FDA UDI
Class IActive
SureFISH Chr3 CEP 592kb P20 GR G110865G
FDA UDI
Class IActive
N2mt-Si N2MT-SI
FDA UDI
Class IActive
SureFISH 14q32.33 IGH DF 1519kb P20 GR5 G210995G
FDA UDI
Class IUnknown
Mono Mo A-Hu Androgen Receptor Cl AR441 M3562
FDA UDI
Class IActive
SureFISH 2p24 MYCN 277kb P5 GR6 G210921G
FDA UDI
Class IUnknown
SureFISH 19q13.43 Chr19qTel 405kb P20 GR G110847G
FDA UDI
Class IUnknown
SureFISH 20q12 MAFB DF 803kb P20 RD G110378R
FDA UDI
Class IActive
SureFISH 21q22.13 ERG 3p BA 426kb P5GR G110915G
FDA UDI
Class IUnknown
SureFISH Chr14 CEP 536kb P20 GR G110871G
FDA UDI
Class IActive
Mono Rb A-Hu AMACR Cl 13H4 M3616
FDA UDI
Class IActive
SureFISH TFE3 3'BA 540kb P5GRx6 G210907G
FDA UDI
Class IUnknown
SureFISH 9q34.3 Chr9qTel 429kb P20 RD G110359R
FDA UDI
Class IUnknown
SureFISH 9p21.3 CDKN2A 351kb P20 GR G110402G
FDA UDI
Class IActive
SureFISH 10p11.22 KIF5B DF 788kb GR6 G210932G
FDA UDI
Class IUnknown
SureFISH 1q21.3 CKS1B 386kb P20 GR G110324G
FDA UDI
Class IActive
SureFISH 17p13.3 Chr17pTel 402kb P20 GR G110842G
FDA UDI
Class IUnknown
SureFISH 1q25.2 ABL2 600kb P20 BL G110736B
FDA UDI
Class IActive
SureFISH 2q13 PAX8 DF 326kb P20 RD G110467R
FDA UDI
Class IActive
SureFISH 2p25.3 Chr2pTel 391kb P20 RD G110345R
FDA UDI
Class IUnknown
SureFISH RET BA P20 G111402
FDA UDI
Class IActive
SureFISH Chr5 CEP 633kb P20 RD G110264R
FDA UDI
Class IActive
SureFISH ALK 5'BA 599kb P20 GR5 G210992G
FDA UDI
Class IUnknown
SureFISH 8q24.21 MYC 294kb P20BL G210977B
FDA UDI
Class IUnknown
SureFISH 19p13.2 SMARCA4 102kb P20 RD G110233R
FDA UDI
Class IUnknown
SureFISH 3q27.3 BCL6 5’ BA 491kb P5 GR G110927G
FDA UDI
Class IUnknown
SureFISH 7p14.1 TRG 3' BA 349kb P20 RD G110702R
FDA UDI
Class IActive
SureFISH Chr16 CEP 671kb P20 BL G110873B
FDA UDI
Class IActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

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