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Agilent Technologies Inc.

United States·US-MF-000009385

Last updated September 17, 2026

What Agilent Technologies Inc. makes

Agilent Technologies Inc. manufactures reagents and instruments for in vitro diagnostics, including nucleic acid hybridization detection kits, microplate washers, automated and semi-automated microplate readers, and electronic liquid dispensers for laboratory use. Their portfolio also includes immunohistochemical staining kits—such as DAB chromogen systems, reticulin, mucicarmine, and Giemsa stains—and mounting media for tissue samples. Negative control immunoglobulins and antibodies targeting melanosomes and cytokeratins are also part of their diagnostic offerings.

The company’s devices are regulated under EU Class A, I, II, and III classifications and are listed in the EUDAMED database and the FDA’s Unique Device Identifier (UDI) system. Agilent Technologies Inc. is headquartered in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

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 17 of 24

Device	Model / Reference	Registries	Class	Status
SureFISH Chr10 CEP 676kb P20 BL	G110884B	FDA UDI	Class I	Active
FLEX Mono Rb A-Hu AMACR Cl 13H4 RTU	IS060	FDA UDI	Class I	Unknown
SureFISH 21q22.2 ERG 5p BA 552kb P5RD	G110916R	FDA UDI	Class I	Unknown
SureFISH Chr17 CEP 436kb P100 GR	G110105G	FDA UDI	Class I	Active
SureFISH 10q23.31 PTEN 160kb P20 RD	G110202R	FDA UDI	Class I	Active
SureFISH 18q21.33 BCL2 5’ BA 598kb P5 GR	G110925G	FDA UDI	Class I	Unknown
SureFISH 21q22.3 Chr21qTel 394kb P20 BL	G110838B	FDA UDI	Class I	Unknown
SureFISH 17q25.3 Chr17qTel 405kb P20 BL	G110843B	FDA UDI	Class I	Unknown
SureFISH 2p16.1 BCL11A 102kb P20 RD	G110752R	FDA UDI	Class I	Active
SureFISH 7q34 TRB 5' BA 583kb P20 GR	G110701G	FDA UDI	Class I	Active
SureFISH 18q21.33 BCL2 5’ BA 598kb P20 GR5	G210989G	FDA UDI	Class I	Unknown
Cyt5v-Si	CYT5V-SI	FDA UDI	Class I	Active
SureFISH 11q13.1 C11orf95 3' 316kb 20 RD	G110477R	FDA UDI	Class I	Unknown
N2sm-Si	N2SM-SI	FDA UDI	Class I	Active
SureFISH 11p15.5 Chr11pTel 408kb P20 GR	G110840G	FDA UDI	Class I	Unknown
Cyt5pv-Si	CYT5PV-SI	FDA UDI	Class I	Active
SureFISH 6p21.32 PHF1 3' BA 616kb P20 GR	G110235G	FDA UDI	Class I	Active
SureFISH 12q13.3 DDIT3 3'BA 537kb P5 RD6	G210922R	FDA UDI	Class I	Unknown
SureFISH 9q34.3 NOTCH1 156kb P20 RD	G110759R	FDA UDI	Class I	Active
SureFISH 18q21 BCL2 3' BA 624kb P5 RD	G110938R	FDA UDI	Class I	Unknown
SureFISH 2p23.2 ALK 479kb P5 RD	G110919R	FDA UDI	Class I	Unknown
SureFISH 16q22.1 CBFB 5' BA 240kb P20 RD	G110244R	FDA UDI	Class I	Active
Dako ER/PR pharmDx Kit For the Dako Autostainer	K4071	FDA UDI	Class II	Unknown
SureFISH 10q26 FGFR2 360kb P5 GR6	G210918G	FDA UDI	Class I	Unknown
SureFISH 2p11.2 IGK 3' BA 252kb P20 RD	G110731R	FDA UDI	Class I	Active
Mono Mo A-Hu Cytokeratin Cls AE1/AE3	M3515	FDA UDI	Class I	Active
SureFISH TFE3 5' BA 237kb P5GRx6	G210906G	FDA UDI	Class I	Unknown
SureFISH 12q13 DDIT3 3' BA 537kb P20GR	G110982G	FDA UDI	Class I	Active
ELx808U-SI	ELx808U-SI	FDA UDI	Class I	Active
SureFISH Xp11.22 CCNB3 683kb P20 RD	G110480R	FDA UDI	Class I	Active
SureFISH 1p36.23 ENO1 763kb P20 RD	G110213R	FDA UDI	Class I	Active
SureFISH 10q26.3 Chr10qTel 391kb P20 GR	G110857G	FDA UDI	Class I	Unknown
Mono Rb A-Hu Postmeiotic Segregation Increased 2 Cl EP51	M3647	FDA UDI	Class I	Active
SureFISH 18q11.2 SS18 5’ 406kb P100 RD	G110111R	FDA UDI	Class I	Active
SureFISH CIC 3' BA 239kb P20 RD	G110203R	FDA UDI	Class I	Active
SureFISH 10q11.21 RET 5' BA 144kb RD	G110928R	FDA UDI	Class I	Unknown
Mfxp1-Si	MFXP1-SI	FDA UDI	Class I	Active
SureFISH Chr2 CEP 448kb P20 RD	G110280R	FDA UDI	Class I	Active
Mono Mo A-Hu Prostate-Specific Membrane Antigen Cl 3E6	M3620	FDA UDI	Class I	Unknown
Dako	IC002	FDA UDI	Class I	Active
Mono Mo A-Hu Melanosome Cl HMB45	M0634	FDA UDI	Class I	Active
SureFISH Chr13 CEP 454kb P20 RD	G110267R	FDA UDI	Class I	Active
FLEX Negative Control Mo Cocktail of Mo IgG1, IgG2a, IgG2b, IgG3 and IgM RTU	IS750	FDA UDI	Class I	Unknown
Slxats-Si	SLXATS-SI	FDA UDI	Class I	Active
FLEX Mono Mo A-Myogenin Cl F5D Ready-to-Use (Dako Omnis)	GA067	FDA UDI	Class I	Active
SureFISH 3p25.2 PPARG 5' BA 398kb P20 RD	G110727R	FDA UDI	Class I	Active
Mono Mo A-Hu Cytokeratin, High Molecular Weight Cl 34ßE12	M0630	FDA UDI	Class I	Active
SureFISH CCND1 DF 577kb P20 RD	G110370R	FDA UDI	Class I	Active
Cyt1v-Si	CYT1V-SI	FDA UDI	Class I	Active
Mono Mo A-Hu Thymidylate Synthase (TS) Cl TS106	M3614	FDA UDI	Class I	Unknown

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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.

Agilent Technologies Inc. has five FDA recall records initiated between June 17, 2015, and March 20, 2025. The records include one classified, one open, and three terminated cases, with reasons involving software defects in LC/MS devices, missing 510(k) clearance for a marketed product, incorrect expiration dates on labels, a genetic component issue in a DNA labeling kit, and a potential structural failure in an automated slide processing system door.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Mar 20, 2025	Z-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, 2024	Z-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, 2022	Z-1384-2022	—	open, classified	Label provided for substrate vail contained incorrect expiration date.
Aug 15, 2018	Z-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, 2015	Z-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