Agilent Technologies Denmark ApS
GLOSTRUP Hovedstaden, DK
Agilent Technologies Denmark ApS appears in FDA device records in GLOSTRUP Hovedstaden, DK. FDA records list 2 510(k) clearances, 19 PMA records and one registered establishment. As of , FDA records show 6 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Agilent Technologies Denmark ApS carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Dako Denmark A/S510(k), PMA, enforcement report, recall
510(k) clearance history
FDA records hold 2 510(k) clearances for Agilent Technologies Denmark ApS in 2017.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2017 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K170028 | FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis) | MYA | Substantially Equivalent | |
| K170005 | FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis) | MXZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9610099 | 3002806778 | Agilent Technologies Denmark ApS | 42 PRODUKTIONSVEJ, GLOSTRUP Hovedstaden DK-2600 DK | 2026 | and 31 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KEMAgent, Clearing
- DDZAlbumin, Fitc, Antigen, Antiserum, Control
- JITCalibrator, Secondary
- NYQChromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer
- CZWComplement C3, Antigen, Antiserum, Control
- DBIComplement C4, Antigen, Antiserum, Control
- GKZCounter, Differential Cell
- KESCoverslips, Microscope Slide
- HYBEosin Y
- LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- NXGFluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion
- PPMGeneral Purpose Reagent
- HYJHematoxylin
- CZPIga, Antigen, Antiserum, Control
- CZNIga, Fitc, Antigen, Antiserum, Control
- DEWIgg, Antigen, Antiserum, Control
- DGKIgg, Fitc, Antigen, Antiserum, Control
- DAOIgm (Mu Chain Specific), Antigen, Antiserum, Control
- DFSIgm, Fitc, Antigen, Antiserum, Control
- JMRImmunochemical, Lysozyme (Muramidase)
- MYAImmunohistochemistry Antibody Assay, Estrogen Receptor
- MXZImmunohistochemistry Assay, Antibody, Progesterone Receptor
- NJTImmunohistochemistry Reagents And Kits
- DFHKappa, Antigen, Antiserum, Control
- DEOKappa, Fitc, Antigen, Antiserum, Control
- DEHLambda, Antigen, Antiserum, Control
- DESLambda, Fitc, Antigen, Antiserum, Control
- OUGMedical Device Data System
- LEBMounting Media
- JZJPrealbumin, Antigen, Antiserum, Control
- GGKProducts, Red-Cell Lysing Products
- MVUReagents, Specific, Analyte
- OTVResearch Use Only/Clinical Chemistry Devices
- OTUResearch Use Only/Pathology
- CZSRetinol-Binding Protein, Antigen, Antiserum, Control
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- KPASlide Stainer, Automated
- KEWSlides, Microscope
- LEEStains, Dye Solution
- JZGSystem, Test, Beta-2-Microglobulin Immunological
- MVCSystem, Test, Her-2/Neu, Ihc
- MVDSystem, Test, Her-2/Neu, Nucleic Acid Or Serum
- NDYTest, Cystatin C
- DGRWhole Human Serum, Antigen, Antiserum, Control
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2565-2025 | Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2J Software Version: Not applicable Product Description: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) is intended for use in immunohistochemistry together with the Dako Omnis instrument. This antibody labels cells of the B-cell lineage and is a useful aid for the classification of neoplasms of B-cell derivation. Component: Not applicable | Their is the potential for weak staining which may result in false negative CD20 identification. | Class II | Open, Classified | |
| Z-2564-2025 | Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2CN Software Version: Not applicable Product Description: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) is intended for use in immunohistochemistry together with the Dako Omnis instrument. This antibody labels cells of the B-cell lineage and is a useful aid for the classification of neoplasms of B-cell derivation. Component: Not applicable | Their is the potential for weak staining which may result in false negative CD20 identification. | Class II | Open, Classified | |
| Z-2563-2025 | Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2 Software Version: Not applicable Product Description: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) is intended for use in immunohistochemistry together with the Dako Omnis instrument. This antibody labels cells of the B-cell lineage and is a useful aid for the classification of neoplasms of B-cell derivation. Component: Not applicable | Their is the potential for weak staining which may result in false negative CD20 identification. | Class II | Open, Classified | |
| Z-2074-2020 | Dako Autostainer instruments: Autostainer Link 48, Model AS480; Autostainer Plus Link Instrument, Model AS100; Autostainer, Model S3400; and Autostainer Plus, Model S3800. | The Autostainer instrument may not have a syringe tray installed which could result in a small volume of excess buffer being applied to several slides. In addition to the syringe tray, the updated Basic User Guide will reduce the potential risk of false negative results in the case of leakage of buffer and/or reagents that may impact staining. | Class II | Terminated | |
| Z-2330-2016 | EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004. Intended for use in immunohistochemistry together with Autostainer Link Instruments. | The pH of Target Retrieval Solution in the kit measures 4-5 instead of the correct pH of 9.1. | Class II | Terminated | |
| Z-0563-2013 | CoverStainer Slide Rack The CoverStainer Slide Rack is an accessory to the CoverStainer instrument. The purpose is to hold microscopic slides, during transfer through the staining process. The rack can hold up to 10 slides at a time, and is necessary for optimal CoverStainer instrument performance. | The expected life time of the CoverStainer slide racks (CS 10330) does not meet established performance requirements, originating from variations in the manufacturing process. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain