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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 1 of 24

Device	Model / Reference	Registries	Class	Status
Dako Liquid DAB+ Substrate Chromogen System	K3467	EUDAMED	Class A	Active
Artisan Reticulin - No Counterstain Kit	AR182	EUDAMED	Class A	Active
Dako Glycergel Mounting Medium	C0563	EUDAMED	Class A	Active
Dako Fluorescence Mounting Medium	S3023	EUDAMED	Class A	Active
Artisan Periodic Schiff Stain Kit	AR165	EUDAMED	Class A	Active
Dako Liquid DAB+ Substrate Chromogen System	K3468	EUDAMED	Class A	Active
Artisan Reticulin-Nuclear Fast Red Stain Kit	AR179	EUDAMED	Class A	Active
Artisan Mucicarmine Stain Kit	AR168	EUDAMED	Class A	Active
Artisan Warthin-Starry Stain Kit	AR181	EUDAMED	Class A	Active
Artisan Giemsa Stain Kit	AR164	EUDAMED	Class A	Active
Dako Wash Buffer 10x	S3006	EUDAMED	Class A	Active
Artisan Reticulin-Nuclear Fast Red Stain Kit	AR179	EUDAMED	Class A	Active
Dako DAB Enhancer	S1961	EUDAMED	Class A	Active
Artisan Orcein Stain Kit	AR313	EUDAMED	Class A	Active
Artisan Alcian Blue/PAS Stain Kit	AR169	EUDAMED	Class A	Active
Artisan Iron Stain Kit	AR158	EUDAMED	Class A	Active
Dako DAB Away DAB Chromogen Removal System	S1967	EUDAMED	Class A	Active
Dako EnVision+ System- HRP Labelled Polymer Anti-Rabbit	K4003	EUDAMED	Class A	Active
Artisan Alcian Blue/PAS/Hematoxylin Stain Kit	AR178	EUDAMED	Class A	Active
Hematoxylin (Link)	SK308	EUDAMED	Class A	Active
Artisan PAS-Green Stain Kit	AR172	EUDAMED	Class A	Active
Dako Antibody Diluent with Background Reducing Components	S3022	EUDAMED	Class A	Active
Dako Proteinase K Ready-to-use	S3020	EUDAMED	Class A	Active
Artisan 50x Wash Solution	AR102	EUDAMED	Class A	Active
Artisan Grocott's Methenamine Silver Stain Kit	AR176	EUDAMED	Class A	Active
Artisan Jones Basement Membrane H&E (PAS-M) Stain Kit	AR480	EUDAMED	Class A	Active
Dako Faramount Aqueous Mounting Medium Ready-to-use	S3025	EUDAMED	Class A	Active
Dako Proteinase K Ready-to-use	S3020	EUDAMED	Class A	Active
Artisan Alcian Blue/PAS/Hematoxylin Stain Kit	AR178	EUDAMED	Class A	Active
Dako Liquid Permanent Red	K0640	EUDAMED	Class A	Active
Dako Mayer's Hematoxylin (Lillie's Modification) Histological Staining Reagent	S3309	EUDAMED	Class A	Active
Artisan Warthin-Starry Stain Kit	AR181	EUDAMED	Class A	Active
Target Retrieval Solution pH 9 (50x) (Dako Omnis)	GC309	EUDAMED	Class A	Active
Artisan Colloidal Iron Stain Kit	AR307	EUDAMED	Class A	Active
Artisan Artisan Maintenance Kit	AR314	EUDAMED	Class A	Active
Artisan Periodic Schiff Stain Kit	AR165	EUDAMED	Class A	Active
Artisan Alcian Blue pH 2.5 Stain Kit	AR160	EUDAMED	Class A	Active
SureFISH 18q21.33 BCL2 5’ BA 598kb P5 RD	G110925R	FDA UDI	Class I	Unknown
SureFISH 18q21 BCL2 3' BA 624kb P5 GR	G110938G	FDA UDI	Class I	Unknown
MAGE-A4 IHC 1F9 pharmDx	SK032	FDA UDI	Class III	Active
SureFISH 2p21 EML4 496kb P5 GR6	G210920G	FDA UDI	Class I	Unknown
SureFISH 21q22.13 ERG DF 777kb P5RDx6	G210913R	FDA UDI	Class I	Unknown
50ts16-Si	50TS16-SI	FDA UDI	Class I	Active
406sna4-Si	406SNA4-SI	FDA UDI	Class I	Active
SureFISH Chr14 CEP 536kb P20 BL	G110871B	FDA UDI	Class I	Active
SureFISH 3q28 BCL6 5’ BA 481kb GR	G110931G	FDA UDI	Class I	Unknown
SureFISH 4q12 PDGFRA TC 481kb P20 BL	G110827B	FDA UDI	Class I	Active
Mono Mo A-Hu Octamer-Binding Transcription Factor 3/4 Cl N1NK	M3649	FDA UDI	Class I	Unknown
Cyt5mfw-Si	CYT5MFW-SI	FDA UDI	Class I	Active
50ts8v-Si	50TS8V-SI	FDA UDI	Class I	Active

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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.

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