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Sign in to claim this brandAgilent 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
- —
- —
- [email protected]
- Phone
- +45 44859756
- PRRC Contact
- Grace Lee
- EUDAMED SRN
- US-MF-000009385
- FDA FEI Number
- 3009189893
- DUNS Number
- —
Catalogue (1184)
Page 4 of 24| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Mono Mo A-Hu PTEN Cl 6H2.1 | M3627 | FDA UDI | Class I | Active |
| SureFISH 12q14.1 CDK4 308kb P20RDX5 | G210978R | FDA UDI | Class I | Unknown |
| Epoch2nsxct | EPOCH2NSXCT | FDA UDI | Class I | Active |
| SureFISH 7q34 BRAF 3' BA 414kb P20 RD | G110399R | FDA UDI | Class I | Active |
| FLEX Mono Mo A-Hu Renal Cell Carcinoma Marker Cl SPM314 RTU (Link) | IR075 | FDA UDI | Class I | Unknown |
| SureFISH ChrX CEP 587kb P20 RD | G110259R | FDA UDI | Class I | Active |
| FLEX Mono Mo A-Hu ERCC1 Cl 4F9 RTU (Link) | IR091 | FDA UDI | Class I | Unknown |
| SureFISH 10q11.21 RET DF 703kb GR6 | G210933G | FDA UDI | Class I | Unknown |
| 405lsuvsq-Si | 405LSUVSQ-SI | FDA UDI | Class I | Active |
| 406pub3-Si | 406PUB3-SI | FDA UDI | Class I | Active |
| Slxfa-Si | SLXFA-SI | FDA UDI | Class I | Active |
| SureFISH Chr1 CEP 541kb P20 RD | G110261R | FDA UDI | Class I | Active |
| SureFISH 21q22.13 ERG 3p BA 426kb P5GRx6 | G210915G | FDA UDI | Class I | Unknown |
| SureFISH 9p21.3 CDKN2A 351kb P20TR | G110973X | FDA UDI | Class I | Unknown |
| N2smab-Si | N2SMAB-SI | FDA UDI | Class I | Active |
| SureFISH 3q27.3 BCL6 3’ BA 371kb P20 RD | G110990R | FDA UDI | Class I | Unknown |
| SureFISH FOXO1 5' BA 601kb P20 RD5 | G210987R | FDA UDI | Class I | Unknown |
| SureFISH Chr6 CEP 706kb P20 RD | G110265R | FDA UDI | Class I | Active |
| 405lsuv-Si | 405LSUV-SI | FDA UDI | Class I | Active |
| SureFISH Chr6 CEP 706kb P20 BL | G110868B | FDA UDI | Class I | Active |
| SureFISH RUNX1 3' BA 563kb P20 RD | G110408R | FDA UDI | Class I | Active |
| SureFISH 17q12 HER2 191kb P100 RD | G110104R | FDA UDI | Class I | Active |
| SureFISH 1p13.2 NRAS 310kb P5GRx6 | G210912G | FDA UDI | Class I | Unknown |
| 406p4-Si | 406P4-SI | FDA UDI | Class I | Active |
| SureFISH Chr21 CEP 653kb P20 BL | G110887B | FDA UDI | Class I | Active |
| SureFISH Chr5 CEP 633kb P20 BL | G110867B | FDA UDI | Class I | Active |
| Bstck2wr-Si | BSTCK2WR-SI | FDA UDI | Class I | Active |
| SureFISH 18q11.2 SS18 3’ 616kb P100 GR | G110110G | FDA UDI | Class I | Active |
| SureFISH 18q23 Chr18qTel 413kb P20 RD | G110313R | FDA UDI | Class I | Unknown |
| SureFISH 17p11.2 RAI1 263kb P20 GR | G110384G | FDA UDI | Class I | Active |
| SureFISH 10q26 FGFR2 360kb P5 GR | G110918G | FDA UDI | Class I | Unknown |
| 405tsrv-Si | 405TSRV-SI | FDA UDI | Class I | Active |
| SureFISH 20p13 Chr20pTel 386kb P20 RD | G110316R | FDA UDI | Class I | Unknown |
| SureFISH 10P12.31 MLLT10 5' BA 673kb GR | G110705G | FDA UDI | Class I | Active |
| Mono Mo A-Hu Papillomavirus (HPV) Clone K1H8 | M3528 | FDA UDI | Class I | Active |
| SureFISH 7q34 BRAF 3' BA 414kb P100 RD | G110112R | FDA UDI | Class I | Active |
| SureFISH 8q13.3 NCOA2 DF 700kb P20 RD | G110287R | FDA UDI | Class I | Active |
| SureFISH 11p15.5 IGF2-TH 100kb P20 RD | G110746R | FDA UDI | Class I | Active |
| SureFISH 10q11.21 RET 5' BA 144kb RD6 | G210928R | FDA UDI | Class I | Unknown |
| Mono Mo A-Hu Mammaglobin Cl 304-1A5 | M3625 | FDA UDI | Class I | Unknown |
| 405lsrvs-Si | 405LSRVS-SI | FDA UDI | Class I | Active |
| SureFISH 6p21.32 PHF1 5' BA 355kb P20 RD | G110234R | FDA UDI | Class I | Active |
| SureFISH 12q15 MDM2 180kb P100 RD | G110108R | FDA UDI | Class I | Active |
| SureFISH 22q13.1 PDGFB DF 919kb P100 GR | G110157G | FDA UDI | Class I | Active |
| SureFISH Chr21 CEP 653kb P20 RD | G110278R | FDA UDI | Class I | Active |
| SureFISH 7q36.1 MLL3 129kb P20 GR | G110757G | FDA UDI | Class I | Active |
| SureFISH 7p22.3 Chr7pTel 426kb P20 BL | G110895B | FDA UDI | Class I | Unknown |
| SureFISH 6p21.1 CCND3 DF 678kb P20 RD | G110379R | FDA UDI | Class I | Active |
| 50ts12v-Si | 50TS12V-SI | FDA UDI | Class I | Active |
| SureFISH 16p11.2 FUS 3' BA 365kb RD6 | G210930R | FDA UDI | Class I | Unknown |
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.
| 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