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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 9 of 24
DeviceModel / ReferenceRegistriesClassStatus
SureFISH 18q21.32 MALT1 DF 672kb P20 RD G110374R
FDA UDI
Class IUnknown
Lp600-Si LP600-SI
FDA UDI
Class IActive
SureFISH 10q11.21 RET 5' BA 144kb GR6 G210928G
FDA UDI
Class IUnknown
SureFISH 11p15.5 Chr11pTel 408kb P20 RD G110333R
FDA UDI
Class IUnknown
SureFISH Chr16 CEP 671kb P20 RD G110270R
FDA UDI
Class IActive
SureFISH Chr20 CEP 687kb P20 GR G110886G
FDA UDI
Class IActive
Bcl2 Ba P20 G111421
FDA UDI
Class IActive
SureFISH 16p11.2 FUS 3' BA 365kb P100 RD G110134R
FDA UDI
Class IActive
K6460 Triple Quadrupole MS – ESI K6460 Triple Quadrupole MS – ESI
FDA UDI
Class IActive
Mono Rb A-Hu Terminal Deoxynucleotidyl Transferase Cl EP266 M3651
FDA UDI
Class IUnknown
SureFISH 8q24.3 Chr8qTel 397kb P20 BL G110897B
FDA UDI
Class IUnknown
FLEX Mono Mo A-Hu CD15 Cl Carb-3 RTU (Dako Omnis) GA062
FDA UDI
Class IActive
SureFISH 9p13.2 PAX5 5' BA 354kb P20 RD G110366R
FDA UDI
Class IUnknown
SureFISH 16p13.1 NDE1-MYH11 445kb P20 GR G110747G
FDA UDI
Class IUnknown
SureFISH 8q21.3 RUNX1T1 DF 734kb P20 RD G110294R
FDA UDI
Class IActive
SureFISH 12q24.33 Chr12qTel 424kb P20 BL G110835B
FDA UDI
Class IUnknown
Mono Mo A-Hu MutS Protein Homolog 2 Cl FE11 M3639
FDA UDI
Class IActive
FLEX Mono Mo A-Hu Progesterone Receptor Clone PgR 636 RTU (Link) IR068
FDA UDI
Class IIActive
SureFISH 9q 21.33 NTRK2 3' BA 445kb RD G110722R
FDA UDI
Class IActive
User-Fillable Reagent Bottle 5mL Capacity (Link) SK200
EUDAMEDFDA UDI
Class IActive
Mono Mo A-Hu Gross Cystic Disease Fluid Protein-15 Cl 23A3 M3638
FDA UDI
Class IUnknown
SureFISH 16p13.3 Chr16pTel 428kb P20 RD G110339R
FDA UDI
Class IUnknown
Mono Mo A-Hu Prostein Cl 10E3 M3615
FDA UDI
Class IUnknown
SureFISH 15q25.3 NTRK3 3' BA 435kb RD G110724R
FDA UDI
Class IActive
1260 Infinity II LC System Clinical Edition 1260 Infinity II LC System
FDA UDI
Class IActive
SureFISH 3q25.1 WWTR1 619kb P20 GR G110217G
FDA UDI
Class IActive
ELx405CV-SI ELx405CV-SI
FDA UDI
Class IActive
SureFISH Chr18 CEP 711kb P20 BL G110874B
FDA UDI
Class IActive
SureFISH 19q13.32 BCL3 3' BA 451kb 20 GR G110290G
FDA UDI
Class IActive
SureFISH Chr17 CEP 436kb P100 BL G110141B
FDA UDI
Class IActive
FLEX Mono Mo A-Hu Melanosome Cl HMB45 RTU (Link) IR052
FDA UDI
Class IActive
SureFISH Chr17 CEP 436kb P20 RD G110291R
FDA UDI
Class IActive
405tsuv-Si 405TSUV-SI
FDA UDI
Class IActive
SureFISH 12p13.33 Chr12pTel 407kb P20 BL G110836B
FDA UDI
Class IUnknown
FLEX Mono Mo A-Hu CD99 MIC2 Gene Product Ewing’s Sarcoma Mark Cl 12E7 RTU (Link) IR057
FDA UDI
Class IActive
SureFISH 1p33 TAL1 5’ BA 75kb P20 RD G110706R
FDA UDI
Class IActive
SureFISH 19p13.3 Chr19pTel 409kb P20 GR G110846G
FDA UDI
Class IUnknown
SureFISH 14q32.33 Chr14qTel 415kb P20 RD G110338R
FDA UDI
Class IUnknown
SureFISH 12q14.1 CDK4 308kb P5RD G110911R
FDA UDI
Class IUnknown
SureFISH 8p11 FGFR1 325kb P20 RD G110397R
FDA UDI
Class IActive
SureFISH 22q11.21 TUPLE1 101kb P20 RD G110295R
FDA UDI
Class IUnknown
SureFISH Xq12 AR 216kb P20 RD G110228R
FDA UDI
Class IActive
SureFISH 17p13.3 YWHAE 172kb P20 RD G110255R
FDA UDI
Class IActive
Cyt5mpv-Si CYT5MPV-SI
FDA UDI
Class IActive
SureFISH 12p13.2 ETV6 5' BA 460kb P20 GR G110274G
FDA UDI
Class IActive
SureFISH 3q28 BCL6 5’ BA 481kb RD6 G210931R
FDA UDI
Class IUnknown
SureFISH 22q11.22 IGL 5' BA 946kb P20 GR G110729G
FDA UDI
Class IActive
SureFISH 4q35.2 Chr4qTel 408kb P20 GR G110349G
FDA UDI
Class IUnknown
SureFISH 14q11 TCRAD 5' BA 468kb P5 RD6 G210936R
FDA UDI
Class IUnknown
Slxfts-Si SLXFTS-SI
FDA UDI
Class IActive

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