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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 12 of 24
DeviceModel / ReferenceRegistriesClassStatus
SureFISH NTRK2 5' BA 406kb P100 GR G110128G
FDA UDI
Class IActive
Cyt7uw-Si CYT7UW-SI
FDA UDI
Class IActive
SureFISH 21q22.13 DSCR8 494kb P20 RD G110285R
FDA UDI
Class IActive
SureFISH 22q13.33 Chr22qTel 383kb P20 RD G110318R
FDA UDI
Class IUnknown
SureFISH 2p24.3 MYCN 277kb P100 RD G110121R
FDA UDI
Class IActive
SureFISH 3q26.32 PIK3CA 167kb P20 RD G110250R
FDA UDI
Class IActive
SureFISH 14q32.33 IGH DF 1519kb P5GR G110903G
FDA UDI
Class IUnknown
405tsusq-Si 405TSUSQ-SI
FDA UDI
Class IActive
SureFISH 1q44 Chr1qTel 402kb P20 RD G110344R
FDA UDI
Class IUnknown
SureFISH Chr16 CEP 671kb P20 GR G110873G
FDA UDI
Class IActive
FLEX Mono Rb A-Hu Cyclin D1, Cl EP12, RTU (Dako Omnis) GA083
FDA UDI
Class IActive
FLEX Mono Mo A-Myogenin Cl F5D RTU IS067
FDA UDI
Class IUnknown
SureFISH 4q24 TET2 133kb P20 RD G110741R
FDA UDI
Class IActive
SureFISH CIC 5' BA 619kb P20 GR G110204G
FDA UDI
Class IActive
SureFISH 2p23.2 ALK 479kb P5 GR G110919G
FDA UDI
Class IUnknown
SureFISH 3q28 TP63 DF 760kb P20 RD G110716R
FDA UDI
Class IActive
406psub2sb-Si 406PSUB2SB-SI
FDA UDI
Class IActive
SureFISH IGH MYC DF P200 G111929
FDA UDI
Class IActive
SureFISH TFE3 3'BA 540kb P5RD G110907R
FDA UDI
Class IUnknown
406pub2-Si 406PUB2-SI
FDA UDI
Class IActive
SureFISH 8q24.21 MYC 5' BA 632kb P20 GR G110458G
FDA UDI
Class IUnknown
SureFISH ALK 3'BA 300kb P20 RD G110387R
FDA UDI
Class IUnknown
SureFISH 3q27.3 BCL6 3’ BA 371kb P5 GR6 G210926G
FDA UDI
Class IUnknown
SureFISH 1p33 STIL 75kb P20 RD G110238R
FDA UDI
Class IActive
Dako ER/PR pharmDx Kit (Link) SK310
FDA UDI
Class IIUnknown
EGFR pharmDx™ K1492
FDA UDI
Class IIIUnknown
SureFISH Xp11.4 BCOR 1009kb P20 GR G110432G
FDA UDI
Class IActive
406psna4-Si 406PSNA4-SI
FDA UDI
Class IActive
SureFISH 3p26.3 Chr3pTel 381kb P20 RD G110347R
FDA UDI
Class IUnknown
SureFISH Chr7 CEP 767kb P20 RD G110286R
FDA UDI
Class IActive
SureFISH 7q34 BRAF 5' BA 510kb P100 GR G110113G
FDA UDI
Class IActive
SureFISH 6q23 MYB 251kb P20 TR G110426X
FDA UDI
Class IActive
SureFISH 9p21.3 CDKN2A 351kb P20 RD G110402R
FDA UDI
Class IActive
SureFISH 4p16.3 FGFR3 405kb P5 GR6 G210917G
FDA UDI
Class IUnknown
FLEX Mono Mo A-Hu CD1a Cl 010 RTU (Link) IR069
FDA UDI
Class IActive
SureFISH 11p15.4 NUP98 3’ BA 132kb 20 RD G110309R
FDA UDI
Class IActive
SureFISH 2p25.3 Chr2pTel 391kb P20 GR G110859G
FDA UDI
Class IUnknown
SureFISH Chr17 CEP 436kb P5GR G110910G
FDA UDI
Class IUnknown
Dako GC202
EUDAMEDFDA UDI
Class IActive
N2-Si N2-SI
FDA UDI
Class IActive
SureFISH 14q11.2 TCRAD 5' BA 468kb P5 RD G110936R
FDA UDI
Class IUnknown
SureFISH 1p36.33 Chr1pTel 417kb P20 GR G110882G
FDA UDI
Class IUnknown
Mono Mo A-Hu Podoplanin Cl D2-40 M3619
FDA UDI
Class IActive
SureFISH FOXO1 5' BA 601kb P100 RD G110117R
FDA UDI
Class IActive
Mono Mo A-Hu COX-2 Cl CX-294 M3617
FDA UDI
Class IUnknown
SureFISH 14q32.2 TCL1 3' BA 504kb P20 GR G110709G
FDA UDI
Class IActive
SureFISH 9q34.3 Chr9qTel 429kb P20 GR G110861G
FDA UDI
Class IUnknown
SureFISH 5p15.33 Chr5pTel 403kb P20 GR G110352G
FDA UDI
Class IUnknown
SureFISH 20p12.2 JAG1 152kb P20 RD G110231R
FDA UDI
Class IUnknown
SureFISH 9p13.2 PAX5 DF 741kb P20 RD G110341R
FDA UDI
Class IActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

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