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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 6 of 24
DeviceModel / ReferenceRegistriesClassStatus
Mono Mo A-Adrenocorticotropin (ACTH) Cl 02A3 M3501
FDA UDI
Class IUnknown
SureFISH 19q13.32 FOSB 5' BA 430kb 20 GR G110474G
FDA UDI
Class IActive
SureFISH 16p11.2 FUS 5' BA 457kb RD G110929R
FDA UDI
Class IUnknown
SureFISH 10q26 FGFR2 360kb P100 RD G110146R
FDA UDI
Class IActive
SureFISH 16p11.2 FUS 5' BA 457kb RD6 G210929R
FDA UDI
Class IUnknown
Af1000a-Si AF1000A-SI
FDA UDI
Class IActive
SureFISH 8q24.21 MYC DF 2726kb P20 RD G110414R
FDA UDI
Class IActive
Cyt5mw-Si CYT5MW-SI
FDA UDI
Class IActive
SureFISH 10q11.21 RET DF 703kb RD6 G210933R
FDA UDI
Class IUnknown
SureFISH CCND1 DF 577kb P20GR G110976G
FDA UDI
Class IActive
SureFISH 21q22.3 Chr21qTel 394kb P20 RD G110307R
FDA UDI
Class IUnknown
SureFISH 18q21 BCL2 5' BA 598kb P5 GR G110937G
FDA UDI
Class IUnknown
FLEX Mono Mo A-Hu MutS Protein Homolog 2 Cl FE11 RTU (Link) IR085
FDA UDI
Class IActive
SureFISH 21q22.13 ERG 3' BA 426kb P20 RD G110802R
FDA UDI
Class IActive
SureFISH Chr6 CEP 706kb P20 GR G110868G
FDA UDI
Class IActive
Cyt5fav-Si CYT5FAV-SI
FDA UDI
Class IActive
SureFISH 1q44 Chr1qTel 402kb P20 BL G110852B
FDA UDI
Class IUnknown
SureFISH 1p13.2 NRAS 310kb P5GR G110912G
FDA UDI
Class IUnknown
SureFISH Chr19 CEP 527kb P20 BL G110875B
FDA UDI
Class IActive
Mono Mo A-Hu Muscle Actin Cl HHF35 M0635
FDA UDI
Class IUnknown
405lsrsq-Si 405LSRSQ-SI
FDA UDI
Class IActive
SureFISH 3q27.3 BCL6 5’ BA 491kb P5 GR6 G210927G
FDA UDI
Class IUnknown
SureFISH 17p13.1 TP53 120kb P20 GR G110383G
FDA UDI
Class IActive
SureFISH 18q21.33 BCL2 3’ BA 389kb P20 RD G110988R
FDA UDI
Class IUnknown
SureFISH 10q11.21 RET DF 703kb GR G110933G
FDA UDI
Class IUnknown
Dako GC206
EUDAMEDFDA UDI
Class IActive
SureFISH 19p13.2 ZNF443 513kb P20 GR G110897G
FDA UDI
Class IActive
SureFISH 11q22.3 ATM 153kb P20 RD G110251R
FDA UDI
Class IActive
SureFISH 18q21 BCL2 5' BA 598kb P5 RD G110937R
FDA UDI
Class IUnknown
SureFISH Chr2 CEP 448kb P100 GR G110122G
FDA UDI
Class IActive
SureFISH 6q22.1 ROS1 3' BA 1132kb P20 GR G110454G
FDA UDI
Class IActive
SureFISH Chr8 CEP 635kb P20 GR G110834G
FDA UDI
Class IActive
SureFISH NTRK3 3' BA 435kb P100 RD G110129R
FDA UDI
Class IActive
SureFISH 9p13.2 PAX5 3' BA 621kb P20 GR G110367G
FDA UDI
Class IUnknown
FLEX Mono Rb A-Hu Cyclin D1 Cl EP12 RTU (Link) IR083
FDA UDI
Class IActive
SureFISH 10q26.3 Chr10qTel 391kb P20 BL G110857B
FDA UDI
Class IUnknown
SureFISH 7q36.3 Ch7qTel 396kb P20 BL G110854B
FDA UDI
Class IUnknown
SureFISH 21q22.2 ERG 5' BA 552kb P20 GR G110816G
FDA UDI
Class IActive
SureFISH 20p13 Chr20pTel 386kb P20 BL G110848B
FDA UDI
Class IUnknown
Mono Mo A-Hu Melanosome Cl HMB45 M0634
FDA UDI
Class IActive
SureFISH ROS1 BA P20X6 G211401
FDA UDI
Class IActive
SureFISH 3p25.2 PPARG 3' BA 400kb P20 GR G110728G
FDA UDI
Class IActive
FLEX Mono Rb A-Hu AMACR Cl 13H4 RTU (Dako Omnis) GA060
FDA UDI
Class IActive
ELx405VS-SI ELx405VS-SI
FDA UDI
Class IActive
SureFISH 9p21.3 CDKN2A 57kb P20 RD G110221R
FDA UDI
Class IActive
SureFISH Xp11.23 TFE3 3' BA 540kb 100 GR G110149G
FDA UDI
Class IActive
406psub1lb-Si 406PSUB1LB-SI
FDA UDI
Class IActive
SureFISH 1q44 Chr1qTel 402kb P20 GR G110852G
FDA UDI
Class IUnknown
SureFISH Chr3 CEP 592kb P100 TR G110143X
FDA UDI
Class IActive
SureFISH 8p23.3 Chr8pTel 406kb P20 BL G110896B
FDA UDI
Class IUnknown

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

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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