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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 18 of 24

Device	Model / Reference	Registries	Class	Status
405tsrsq-Si	405TSRSQ-SI	FDA UDI	Class I	Active
SureFISH PDGFB 5' BA 429kb P20 GR	G110404G	FDA UDI	Class I	Active
SureFISH 19q13.43 Chr19qTel 405kb P20 RD	G110315R	FDA UDI	Class I	Unknown
SureFISH 16p13.1 MYH11 DF 445kb P20 RD	G110421R	FDA UDI	Class I	Unknown
SureFISH Xq28 MECP2 83kb P20 RD	G110739R	FDA UDI	Class I	Active
Mono Mo A-Hu CDX2 Cl DAK-CDX2	M3636	FDA UDI	Class I	Active
SureFISH 21q22.12 RUNX1 DF 672kb P20 GR	G110230G	FDA UDI	Class I	Active
SureFISH 3q29 Chr3qTel 380kb P20 RD	G110319R	FDA UDI	Class I	Unknown
405lsrs-Si	405LSRS-SI	FDA UDI	Class I	Active
SureFISH 16q24.3 Chr16qTel 424kb P20 GR	G110877G	FDA UDI	Class I	Unknown
SureFISH ROS1 BA P200	G111901	FDA UDI	Class I	Active
SureFISH 3q26.2 MECOM 3' BA 451kb P20 GR	G110447G	FDA UDI	Class I	Active
SureFISH 11q24.3 FLI1 DF 770kb P20 RD	G110464R	FDA UDI	Class I	Active
SureFISH NTRK1 3' BA 380kb P100 RD	G110126R	FDA UDI	Class I	Active
Sh1mselux	SH1MSELUX	FDA UDI	Class I	Active
SureFISH 11q25 Chr11qTel 398kb P20 GR	G110837G	FDA UDI	Class I	Unknown
SureFISH 21q22.3 TMPRSS2 DF 873kb P5GR	G110914G	FDA UDI	Class I	Unknown
SureFISH 9p21.3 CDKN2A 351kb P20TR	G210973X	FDA UDI	Class I	Unknown
SureFISH 4p16.3 FGFR3 3' BA 373kb P20 GR	G110471G	FDA UDI	Class I	Active
SureFISH 6p25.3 DUSP22 IRF4 5' 48kb RD	G110712R	FDA UDI	Class I	Active
SureFISH ChrX CEP 587kb P20 BL	G110862B	FDA UDI	Class I	Active
SureFISH NUP214 3’ BA 447kb P20 RD	G110322R	FDA UDI	Class I	Unknown
SureFISH 11q21 MAML2 3' BA 399kb P100 GR	G110154G	FDA UDI	Class I	Active
SureFISH 13q14.3 D13S25 197kb P20 RD	G110377R	FDA UDI	Class I	Active
SureFISH Chr4 CEP 613kb P20 RD	G110263R	FDA UDI	Class I	Active
SureFISH 10q11.21 RET DF 703kb RD	G110933R	FDA UDI	Class I	Unknown
SureFISH 3q27.3 BCL6 3’ BA 371kb P20 RD5	G210990R	FDA UDI	Class I	Unknown
ELx405CS-SI	ELx405CS-SI	FDA UDI	Class I	Active
SureFISH 16q23.2 MAF DF 604kb P100 RD	G110138R	FDA UDI	Class I	Active
Biospag-Si	BIOSPAG-SI	FDA UDI	Class I	Active
SureFISH EWSR1 3' BA 263kb P20 RD	G110392R	FDA UDI	Class I	Active
SureFISH NTRK1 3' 140kb P20 RD	G110214R	FDA UDI	Class I	Active
SureFISH 13q34 LAMP1 598kb P20 BL	G110800B	FDA UDI	Class I	Active
SureFISH 4p16.3 FGFR3 405kb P5 RD6	G210917R	FDA UDI	Class I	Unknown
SureFISH 10p12.31 MLLT10 3' BA 465kb RD	G110704R	FDA UDI	Class I	Active
SureFISH 17q25.3 ASPSCR1 406kb P20 GR	G110435G	FDA UDI	Class I	Active
SureFISH 17p13.3 PAFAH1B1 149kb P20 RD	G110256R	FDA UDI	Class I	Unknown
SureFISH 18q21.33 BCL2 3’ BA 389kb P5RD6	G210924R	FDA UDI	Class I	Unknown
SureFISH 13q14.2 RB1 522kb P20 RD	G110284R	FDA UDI	Class I	Active
SureFISH 3q28 BCL6 5’ BA 481kb P20 GR5	G210991G	FDA UDI	Class I	Unknown
SureFISH 10p15.3 Chr10pTel 372kb P20 GR	G110856G	FDA UDI	Class I	Unknown
Poly Rb A-Cytokeratin Wide Spectrum Screening	Z0622	FDA UDI	Class I	Unknown
SureFISH Chr17 CEP 436kb P5RD	G110910R	FDA UDI	Class I	Unknown
FLEX Mono Mo A-Hu MutL Protein Homolog 1 Cl ES05 RTU (Link)	IR079	FDA UDI	Class I	Active
Dako	IS075	FDA UDI	Class I	Unknown
Biospa-Si	BIOSPA-SI	FDA UDI	Class I	Active
SureFISH 8p12 NRG1 3' BA 248kb P20 RD	G110218R	FDA UDI	Class I	Active
SureFISH 9p21.3 CDKN2A 351kb P100 TR	G110142X	FDA UDI	Class I	Unknown
Bcl6 Ba P20	G111422	FDA UDI	Class I	Active
FLEX Mono Mo A-Hu CDX2 Cl DAK-CDX2 RTU	IS080	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