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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 10 of 24
DeviceModel / ReferenceRegistriesClassStatus
FLEX Mono Rb A-Hu Estrogen Receptor a, Cl EP1, RTU (Dako Omnis) GA084
FDA UDI
Class IIActive
SureFISH 2p24 MYCN 277kb P5 GR G110921G
FDA UDI
Class IUnknown
SureFISH 5q35 NSD1 240kb P20 RD G110755R
FDA UDI
Class IActive
Mono Mo A-Hu CDX2 Cl DAK-CDX2 M3636
FDA UDI
Class IActive
Mono Mo A-Hu Cytokeratin, High Molecular Weight Cl 34ßE12 M0630
FDA UDI
Class IActive
FLEX Mono Mo A-Hu E-Cadherin Cl NCH-38 RTU IS059
FDA UDI
Class IUnknown
SureFISH TFE3 3'BA 540kb P5RDx6 G210907R
FDA UDI
Class IUnknown
Lfx-Si LFX-SI
FDA UDI
Class IActive
SureFISH IGH BCL2 DF P200 G111930
FDA UDI
Class IActive
SureFISH 7p11.2 EGFR 188kb P5RD G110901R
FDA UDI
Class IUnknown
SureFISH Xp11.23 TFE3 5' BA 237kb P20 RD G110459R
FDA UDI
Class IActive
SureFISH 17q12 HER2 191kb P20GRX5 G210969G
FDA UDI
Class IUnknown
SureFISH 8p11.23 FGFR1 3’ BA 393kb 20 GR G110469G
FDA UDI
Class IActive
SureFISH 11p15.4 NUP98 5’ BA 416kb 20 GR G110441G
FDA UDI
Class IActive
SureFISH 11q21 MAML2 5' BA 264kb P100 RD G110155R
FDA UDI
Class IActive
SureFISH 7p11.2 EGFR 188kb P5RDx6 G210901R
FDA UDI
Class IUnknown
SureFISH PML RARA DF G110425
FDA UDI
Class IActive
User-Fillable Reagent Bottle 12mL Capacity (Link) SK201
FDA UDI
Class IActive
SureFISH RUNX1 5’ BA 569kb P20 GR G110409G
FDA UDI
Class IActive
FLEX Mono Mo A-Hu Tyrosinase Cl T311 RTU (Link) IR061
FDA UDI
Class IActive
SureFISH 17p13.3 Chr17pTel 402kb P20 RD G110310R
FDA UDI
Class IUnknown
SureFISH 3q26.32 TBL1XR1 DF 846kb P20 GR G110717G
FDA UDI
Class IActive
SureFISH 2q37.3 Chr2qTel 415kb P20 GR G110885G
FDA UDI
Class IUnknown
Mono Mo A-Hu Renal Cell Carcinoma Cl SPM314 M3632
FDA UDI
Class IUnknown
SureFISH Chr9 CEP 367kb P20 BL G110869B
FDA UDI
Class IActive
SureFISH 9p21.3 CDKN2A 351kb P100 GO G110142Y
FDA UDI
Class IActive
PD-L1 IHC 28-8 pharmDx SK005
FDA UDI
Class IIIActive
SureFISH 11q13.1 MALAT1 328kb P20 RD G110239R
FDA UDI
Class IUnknown
SureFISH 19p13.3 Chr19pTel 409kb P20 BL G110846B
FDA UDI
Class IUnknown
SureFISH 1p36.32 TPRG1L 332kb P20 RD G110385R
FDA UDI
Class IActive
SureFISH 11p13 WT1 89kb P20 RD G110738R
FDA UDI
Class IActive
C10pwc-Si C10PWC-SI
FDA UDI
Class IActive
Igh Ccnd1 Df P20 G111442
FDA UDI
Class IActive
SureFISH Chr2 CEP 448kb P20 BL G110889B
FDA UDI
Class IActive
FLEX Mono Mo A-Hu Inhibin a Cl R1 RTU (Link) IR058
FDA UDI
Class IActive
SureFISH Xp11.23 TFE3 3' BA 540kb P20 GR G110460G
FDA UDI
Class IActive
SureFISH 5q35.3 Chr5qTel 397kb P20 GR G110892G
FDA UDI
Class IUnknown
SureFISH 17q21.33 COL1A1 DF 789kb 100 RD G110156R
FDA UDI
Class IActive
FLEX Mono Mo A-Thyroid Transcription Factor, TTF-1 Cl 8G7G3/1 RTU IS056
FDA UDI
Class IUnknown
SureFISH 7q31.2 MET 400kb P5RD G110900R
FDA UDI
Class IUnknown
SureFISH Chr17 CEP 436kb P5GRx6 G210910G
FDA UDI
Class IUnknown
SureFISH ALK 3' BA 300kb P5RD G110908R
FDA UDI
Class IUnknown
SureFISH 18q21.33 BCL2 5’ BA 598kb P5RD6 G210925R
FDA UDI
Class IUnknown
SureFISH 16p11.2 FUS 5' BA 457kb P100 GR G110133G
FDA UDI
Class IActive
SureFISH 18q11.2 SS18 5’ BA 406kb P20 RD G110394R
FDA UDI
Class IActive
SureFISH 21q22.13 ERG DF 777kb P5GRx6 G210913G
FDA UDI
Class IUnknown
SureFISH 14q11.2 TCRAD 5' BA 468kb P5 GR G110936G
FDA UDI
Class IUnknown
N2mbt-Si N2MBT-SI
FDA UDI
Class IActive
C10pw-Si C10PW-SI
FDA UDI
Class IActive
SureFISH 14q32.33 IGH DF 1519kb P5GRx6 G210903G
FDA UDI
Class IUnknown

Related Companies

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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