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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 8 of 24
DeviceModel / ReferenceRegistriesClassStatus
SureFISH 11q22.2 MMP7 312kb P20 RD G110240R
FDA UDI
Class IActive
Igh Myc Df P20 G111425
FDA UDI
Class IActive
Dako K1907
FDA UDI
Class IIIUnknown
SureFISH 21q22.13 ERG 3p BA 426kb P5RDx6 G210915R
FDA UDI
Class IUnknown
SureFISH 17q12 HER2 191kb P5 GR G110909G
FDA UDI
Class IUnknown
Mono Mo A-MyoD1 Cl 5.8A M3512
FDA UDI
Class IUnknown
FLEX Mono Mo A-Hu Cytokeratin Cl AE1/AE3 RTU IS053
FDA UDI
Class IUnknown
SureFISH 9p24.3 Chr9pTel 428kb P20 BL G110898B
FDA UDI
Class IUnknown
SureFISH 18p11.32 Chr18pTel 403kb P20 BL G110844B
FDA UDI
Class IUnknown
SureFISH Chr4 CEP 613kb P20 GR G110866G
FDA UDI
Class IActive
SureFISH 9q34.12 ABL1 3' BA 350kb P20 GR G110420G
FDA UDI
Class IActive
SureFISH 6p25.1 RREB1 638kb P20 GR G110401G
FDA UDI
Class IActive
Dako IC004
FDA UDI
Class IUnknown
SureFISH 17q21.31 KANSL1 186kb P20 GR G110433G
FDA UDI
Class IActive
SureFISH 3q26 TERC 1014kb P20 RD G110211R
FDA UDI
Class IActive
SureFISH Yp11.31 SRY 131kb P20 RD G110300R
FDA UDI
Class IUnknown
SureFISH 3q28 BCL6 5’ BA 481kb RD G110931R
FDA UDI
Class IUnknown
SureFISH 19p13.3 TCF3 DF 729kb P20 GR G110293G
FDA UDI
Class IActive
SureFISH 3q27.3 BCL6 3’ BA 371kb P5 GR G110926G
FDA UDI
Class IUnknown
SureFISH 1p32.3 CDKN2C 426kb P20 GR G110858G
FDA UDI
Class IActive
SureFISH RET BA P200 G111902
FDA UDI
Class IActive
SureFISH 1p13.2 NRAS 310kb P5RDx6 G210912R
FDA UDI
Class IUnknown
Fragile X Fluorescein-Labelled Probe Y1442
FDA UDI
Class IActive
User-Fillable Reagent Bottle 50mL Capacity (Link) SK203
FDA UDI
Class IActive
SureFISH Chr9 CEP 367kb P20GRX5 G210975G
FDA UDI
Class IUnknown
Mfxp2r-Si MFXP2R-SI
FDA UDI
Class IActive
SureFISH FOXO1 5' BA 601kb P5 GR G110905G
FDA UDI
Class IUnknown
SureFISH 12q13.3 DDIT3 3' BA 537kb P5 RD G110922R
FDA UDI
Class IUnknown
SureFISH 9p21.3 CDKN2A 351kb P20GO G210973Y
FDA UDI
Class IUnknown
SureFISH 1q21.1 CD160 122kb P20 RD G110745R
FDA UDI
Class IUnknown
SureFISH ChrY CEP 273kb P20 RD G110260R
FDA UDI
Class IActive
SureFISH 20q13.33 Chr20qTel 379kb P20 BL G110849B
FDA UDI
Class IUnknown
406psub3lb-Si 406PSUB3LB-SI
FDA UDI
Class IActive
Igh Ccnd1 Df P200 G111931
FDA UDI
Class IActive
Cyt5mfv-Si CYT5MFV-SI
FDA UDI
Class IActive
Mono Mo A-Hu Epithelial Related Antigen Cl MOC-31 M3525
FDA UDI
Class IActive
SureFISH Chr14 CEP 536kb P20 RD G110268R
FDA UDI
Class IActive
SureFISH 21q22.3 TMPRSS2 5' TC 529kb BL G110820B
FDA UDI
Class IActive
SureFISH TFE3 3'BA 540kb P5GR G110907G
FDA UDI
Class IUnknown
SureFISH 1p32.3 CDKN2C 153kb P20 RD G110376R
FDA UDI
Class IActive
SureFISH 7q31.2 MET 400kb P20 RD5 G210994R
FDA UDI
Class IUnknown
SureFISH RET BA P5 G111202
FDA UDI
Class IUnknown
SureFISH Chr10 CEP 676kb P100 GR G110124G
FDA UDI
Class IActive
405tsrs-Si 405TSRS-SI
FDA UDI
Class IActive
SureFISH 19p13.2 EPOR 5' BA 291kb P20 GR G110413G
FDA UDI
Class IActive
SureFISH 14q32.33 Chr14qTel 415kb P20 GR G110851G
FDA UDI
Class IUnknown
SureFISH 10q11.21 RET 5' BA 144kb GR G110928G
FDA UDI
Class IUnknown
SureFISH Chr11 CEP 798kb P20 RD G110275R
FDA UDI
Class IActive
SureFISH Chr20 CEP 687kb P20 BL G110886B
FDA UDI
Class IActive
SureFISH 16q23.2 MAF DF 850kb P20 RD G110380R
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