Agilent Technologies Denmark ApS

FDA Device Registration & Listing · GLOSTRUP Hovedstaden, DK · Registration 9610099

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9610099
FEI Number
3002806778
Entity Name
Agilent Technologies Denmark ApS
City/State/Country
GLOSTRUP Hovedstaden, DK
Establishment Address
42 PRODUKTIONSVEJ, GLOSTRUP Hovedstaden DK-2600, DK
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Agilent Technologies, Inc (Owner Number: 10038794)
Owner / Operator Contact Address
5301 Stevens Creek Blvd, Santa Clara, CA 95051, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

HER2 IQFISH pharmDx MultiMix Dual-Colour Reagent, Anti-Human CD3/FITC + Anti-Human CD19/RPE Monoclonal Mouse Anti-Human CD4/FITC, Clone MT310 Monoclonal Mouse Anti-Human CD4/RPE, Clone MT310 Negative Control, Mouse IgG1/RPE-Cy5 Negative Control, Mouse IgG1/FITC Negative Control, Mouse IgG1/RPE MultiMix Dual-Colour Reagent, Anti-Human CD45/FITC + Anti-Human CD14/RPE Monoclonal Mouse Anti-Human CD3/RPE-Cy5, Clone UCHT1 Monoclonal Mouse Anti-Human CD3/RPE, Clone UCHT1 Monoclonal Mouse Anti-Human CD19/RPE, Clone HD37 Polyclonal Rabbit Anti-Human Kappa Light Chains/FITC Dako Target Retrieval Solution, pH 9, (10x), (3-in-1) Antibody Diluent Dako Target Retrieval Solution, pH 9 (x 10) Dako Target Retrieval Solution, pH 9, Ready-to-Use AEC Substrate-Chromogen, Ready-to-Use Dako DAB Enhancer Dako Antibody Diluent with Background-Reducing Components Fluorescence Mounting Medium (Dako Omnis) EnVision FLEX DAB Enhancer (Dako Omnis) Polyclonal Swine Anti-Rabbit Immunoglobulins/HRP EnVision FLEX+, Mouse, High pH, (Link) EnVision FLEX Mini Kit, High pH (Link) Streptavidin/HRP Polyclonal Goat Anti-Mouse Immunoglobulins/HRP Polyclonal Goat Anti-Mouse Immunoglobulins/AP ISH Pre-Treatment Solution (20x) (Dako Omnis) Permanent Red Substrate System Dako REAL Detection System, Peroxidase/AEC, Rabbit/Mouse Fluorescence Mounting Medium Polyclonal Swine Anti-Goat, Mouse, Rabbit Immunoglobulins/Biotinylated, Multi-Link EnVision FLEX+ Rabbit (LINKER) (Automated Link Platforms) Dako Turbidimetry/Nephelometry Reaction Buffer 2 Levamisole Solution Polyclonal Swine Anti-Rabbit Immunoglobulins/Biotinylated, Swine F(ab')2 Ultramount, Aqueous Permanent Mounting Medium, Ready-to-Use DAB Away Chemiluminescent System for Nucleic Acid Blotting Polyclonal Rabbit Anti-Mouse Immunoglobulins/FITC, Rabbit F(ab')2 EnVision FLEX Target Retrieval Solution, Low pH (50x) (Dako Omnis) ISH Cleaning Solution (Dako Omnis) EnVision FLEX+ Rabbit LINKER (Dako Omnis) Clear-It Cleaning Reagent for Special Stains Polyclonal Goat Anti-Mouse Immunoglobulins/Biotinylated Polyclonal Rabbit Anti-Mouse Immunoglobulins/HRP Biotin Blocking System Dako REAL Antibody Diluent Envision DuoFlex Doublestain System EnVision FLEX Antibody Diluent (Link) ISH Starter Pack - Dako Omnis. Contains GM300, GM301, GM302, GM303, GM304 and GC102 Stringent Wash (2X SSC), Nucleic Acid Blotting Polyclonal Rabbit Anti-Mouse Immunoglobulins/FITC Tris-Buffered Saline (TBS) EnVision FLEX Wash Buffer (20x) EnVision FLEX+ Rabbit (LINKER) (Dako Autostainer/Autostainer Plus) Pepsin Glycergel, Aqueous Mounting Medium EnVision FLEX, High pH, (Link) Protein Block Serum Free EnVision FLEX, High pH (Dako Omnis) ISH Stringent Wash Buffer (20x) (Dako Omnis) Polyclonal Rabbit Anti-Human Gastrin Polyclonal Swine Anti-Rabbit Immunoglobulins/FITC, Swine F(ab')2 ISH Ethanol Solution 96% (Dako Omnis) Polyclonal Rabbit Anti-Mouse Immunoglobulins/Biotinylated, Rabbit F(ab')2 CSA II System, Biotin Free Proteolytic Enzyme, Ready-to-Use Proteinase K (Concentrate) Dako Omnis Sulfuric Acid, 0.3 M Tween 20 Fuchsin+ Substrate-Chromogen PNA ISH Detection Kit Polyclonal Goat Anti-Rabbit Immunoglobulins/Biotinylated Wash Buffer (20x) (Dako Omnis) ADVANCE HRP Phosphate-Buffered Saline (PBS), pH 7 EnVision+ System/HRP, Mouse (AEC+) Polyclonal Rabbit Anti-Goat Immunoglobulins/HRP Dako GenPoint Tyramide Signal Amplification System for Biotinylated Probes Polyclonal Rabbit Anti-Rat Immunoglobulins/HRP Dual Endogenous Enzyme Block Polyclonal Rabbit Anti-Goat Immunoglobulins/Biotinylated Dako REAL EnVision Detection System, Peroxidase/DAB, Rabbit/Mouse Dako REAL Detection System, Alkaline Phosphatase/RED, Rabbit/Mouse Polyclonal Goat Anti-Mouse Immunoglobulins/FITC, Goat F(ab')2* Polyclonal Rabbit Anti-Human IgG/AP EnVision+/HRP, Rabbit Polyclonal Rabbit Anti-Mouse Immunoglobulins/Biotinylated Polyclonal Rabbit Anti-Mouse Immunoglobulins/AP EnVision FLEX Mini Kit, High pH, (Dako Autostainer/Autostainer Plus) Polyclonal Goat Anti-Mouse Immunoglobulins/RPE, Goat F(ab')2 EnVision FLEX HRP Magenta Substrate Chromogen System (Dako Omnis) EnVision+ Detection System, Peroxidase/DAB, Rabbit/Mouse Histology FISH Accessory Kit Polyclonal Goat Anti-Rabbit Immunoglobulins/AP EnVision+ System/HRP, Rabbit (AEC+) Dako Wash Buffer 10x Dako REAL Peroxidase-Blocking Solution EnVision+ System/HRP, Rabbit (DAB+) EnVision FLEX DAB+ Substrate Chromogen System (Dako Omnis) FISH Hybridization Buffer and Mounting Buffer Hybridization Solution, Nucleic Acid Blotting EnVision FLEX Target Retrieval Solution, High pH (50x) (Automated Link Platforms) Proteinase K, Ready-to-Use EnVision FLEX+ Mouse (LINKER) (Link) EnVision FLEX+ Mouse (LINKER) (Dako Autostainer/Autostainer Plus) Target Retrieval Solution, Concentrated x 10 EnVision FLEX Target Retrieval Solution, Low pH (50x) (Link) Polyclonal Rabbit Anti-Mouse Immunoglobulins/RPE, Rabbit F(ab')2 Tris-Buffered NaCl Solution with Tween 20 (TBST), pH 7.6, Concentrated x 10 Dako Pen AEC+ Substrate-Chromogen, Ready-to-Use In Situ Hybridization Detection System (AP), for Biotinylated Probes Tris-Buffered Saline (TBS), pH 7.6 Polyclonal Rabbit Anti-Mouse Immunoglobulins Cytology FISH Accessory Kit Instrument Cleaning Kit (Link) EnVision FLEX HRP Magenta, High pH (Dako Omnis) Polyclonal Goat Anti-Rabbit Immunoglobulins/HRP Polyclonal Swine Anti-Rabbit Immunoglobulins/AP Faramount, Aqueous Mounting Medium, Ready-to-Use Target Retrieval Solution FISH Hybridization Buffer EnVision G 2 System/AP, Rabbit/Mouse (Permanent Red) EnVision FLEX+ Mouse LINKER (Dako Omnis) EnVision FLEX Target Retrieval Solution, High pH (50x) (Dako Omnis) EnVision + Detection System, Peroxidase/DAB, Rabbit/Mouse Dako LSAB2 System-HRP IQFISH Fast Hybridization Buffer Artisan Clearing Solution EnVision FLEX, High pH (Dako Autostainer/Autostainer Plus) Dako TMB Blue EnVision+/HRP, Dual Link Rabbit/Mouse Polyclonal Rabbit Anti-Sheep Immunoglobulins/HRP Polyclonal Swine Anti-Rabbit Immunoglobulins/FITC GenetiSure Dx CGH Wash Buffer 1,4L Polyclonal Rabbit Anti-Goat Immunoglobulins/FITC EnVision FLEX Mini Kit, High pH (Dako Autostainer/Autostainer Plus) Artisan Wash Solution (50x) EnVision FLEX Mini Kit, High pH (Dako Omnis) AEC+ High Sensitivity Substrate Chromogen, Ready-to-Use Dako Target Retrieval Solution, Citrate pH 6 (x 10) EnVision+/HRP, Mouse EnVision FLEX+, Mouse, High pH (Dako Autostainer/Autostainer Plus) Polyclonal Swine Anti-Rabbit Immunoglobulins/Biotinylated EnVision G 2 Doublestain System, Rabbit/Mouse (DAB+/Permanent Red) Dako Turbidimetry/Nephelometry Reaction Buffer 4 FISH Wash Buffer 2 EnVision+ System/HRP, Mouse (DAB+) Polyclonal Rabbit Anti-Guinea Pig Immunoglobulins/HRP Dako Liquid Permanent Red ISH Pepsin (Dako Omnis) Dako TMB+ Liquid DAB+ CSA II Rabbit Link IQFISH Fast Hybridization Buffer 200uL FISH Wash Buffer 1 FISH Hybridization Buffer and Mounting Buffer with DAPI, 3-pack Anti-FITC-AP CISH Accessory Kit IQFISH Fast Hybridization Buffer 900uL FISH Hybridization Buffer and Mounting Buffer, 3-pack FISH Mounting Buffer FISH Hybridization Buffer and Mounting Buffer with DAPI GenetiSure Dx CGH Wash Buffer 2,4L BCIP/NBT Substrate System FISH FFPE Hybridization Buffer FISH Mounting Buffer with DAPI Artisan Maintenance Kit ISH Pepsin Kit Instrument Cleaning Kit for Automated Link Platforms Target Retrieval Solution, pH 9 (50x) (Dako Omnis) Target Retrieval Solution pH 9 (50x) Polyclonal Rabbit Anti-Human IgA/FITC Polyclonal Rabbit Anti-Human Lysozyme EC 3.2.1.17 FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis) Polyclonal Rabbit Anti-Human Lambda Light Chains Polyclonal Rabbit Anti-Human C3c Complement/FITC Dako Omnis 165 Dako Omnis Waste Tank (Hz) Dako Omnis Waste Container Steel Dako Omnis Certified Pre-Owned, RoHS Dako Omnis Buffer/Solvent Container Label User-Fillable Reagent Bottle 12mL Capacity (Link) User-Fillable Reagent Bottle 50mL Capacity (Link) Dako Omnis Dako Omnis Reagent Rack Dako Omnis ISH Lid Dako Omnis Slide Racks, 6 pcs User-Fillable Reagent Bottle 5mL Capacity (Link) Dako Coverstainer Slide Rack Artisan Link Autostainer Plus Link, Calibration Bottle Kit Dako Omnis Buffer/Solvent Container Dako CoverStainer Dako CoverStainer Dip Tank Dako Omnis Vial with Mixing Ball, 2 mL Dako Omnis Water container Autostainer Link 48 Artisan Link Pro Dako Omnis Small Vial, 2 mL User-Fillable Reagent Bottle 25mL Capacity (Link) Dako Omnis Large Vial, 30 mL Artisan Filter Dako Distribution Plates, 2 pcs, CoverStainer Dako Omnis Mixing Device Dako Distribution Plates, 10 pcs, CoverStainer Autostainer Slide Racks, 4 Pack Dako Omnis DI Water Filling Accessories Dako Omnis 165 Duo Dako Omnis Clean Liquid System Hardware Dako Omnis Waste Accessories (Direct) Dako Omnis 110 Dako Omnis Waste Accessories (Indirect) Dako Omnis Waste Tank (NHz) Dako Omnis DI Water Tank Dako Omnis Waste Container 7 L Cystatin C Control Set Monoclonal Mouse Anti-Human CD3/FITC, Clone UCHT1 FLEX IHC Microscope Slides Silanized Slides Polyclonal Rabbit Anti-Human IgM/FITC Polyclonal Rabbit Anti-Human C4c Complement/FITC Polyclonal Rabbit Anti-Human IgG Artisan Elastic Stain Kit Hematoxylin, for the Dako Autostainer Hematoxylin Histological Staining Reagent Dako Harris Hematoxylin Hematoxylin (Dako Omnis) Hematoxylin (Link) Dako Hematoxylin EnVision FLEX Hematoxylin (Automated Link Platforms) Dako Gill's 3 Hematoxylin Uti-Lyse, Erythrocyte-Lysing Reagent EasyLyse, Erythrocyte-Lysing Reagent IntraStain DAKO COVER GLASS 24 x 50 mm Ulisa 6.1x ULISA 6.2x HercepTest for Automated Link Platforms Clearify Polyclonal Rabbit Anti-Human Lambda Light Chains/FITC MultiMix Dual-Colour Reagent, Anti-Human CD4/FITC + Anti-Human CD8/RPE Polyclonal Rabbit Anti-Human IgG/FITC Monoclonal Mouse Anti-Human Integrin Beta-6, Clone 6.2A1 Monoclonal Mouse Anti-Human CD43/FITC, Clone DF-T1 Polyclonal Rabbit Anti-Human Kappa Light Chains/FITC, Rabbit F(ab')2 Monoclonal Mouse Anti-Human CD138/APC, Clone MI15 Monoclonal Mouse Anti-Human CD16, Fc Gamma Receptor III/FITC, Clone DJ130c Monoclonal Mouse Anti-Human CD79/FITC, Clone SN8 BCL2 FISH DNA Probe, Split Signal Isotype Reagent, Mouse IgG1/PB Monoclonal Mouse Anti-Human CD56/RPE, Clone MOC-1 Isotype Reagent, Mouse IgG1/APC Monoclonal Mouse Anti-Human CD22/APC, Clone 4KB128 Polyclonal Rabbit Anti-Human IgD/RPE, Rabbit F(ab')2 Monoclonal Mouse Anti-Human CD11b, C3bi Receptor/RPE, Clone 2LPM19c Monoclonal Mouse Anti-Human CD13/RPE, Clone WM-47 Polyclonal Rabbit Anti-Human Lambda Light Chains/FITC, Rabbit F(ab')2 B and T-Cell Gene Rearrangement Probe, TcRBC, Fluorescein Monoclonal Mouse Anti-Human CD8/PB, Clone DK25 Monoclonal Mouse Anti-Human CD1a/PerCP-Cy5.5, clone NA1/34 Isotype Reagent, Mouse IgM/FITC Monoclonal Mouse Anti-Human CD22/FITC, Clone 4KB128 Monoclonal Mouse Anti-Human CD23/FITC, Clone MHM6 IGL FISH DNA Probe, Split Signal Monoclonal Mouse Anti-Human CD7/FITC, Clone DK24 Monoclonal Mouse Anti-Human CD11c, Protein 150,95/FITC, Clone KB90 Monoclonal Mouse Anti-Human CD3/PB, Clone UCHT1 MultiMix Dual-Colour Reagent, Anti-Human Lambda Light Chains/FITC + Anti-Human CD19/RPE Monoclonal Mouse Anti-Human CD45R0/FITC, Clone UCHL1 Monoclonal Mouse Anti-Human CD13/FITC, Clone WM-47 Monoclonal Mouse Anti-Human CD68/FITC, Clone KP1 MultiMix" Dual-Colour Control Reagent, Rabbit F(ab')2/FITC + Rabbit F(ab')2/RPE Monoclonal Mouse Anti-Human CD4/APC, Clone MT310 Monoclonal Mouse Anti-Human CD56/RPE, Clone C5.9 Isotype Reagent Mouse IgG1/PerCP-5.5 Monoclonal Mouse Anti-Human Ki-67 Antigen/FITC, Clone Ki-67 Monoclonal Mouse Anti-Cytomegalovirus, Clones CCH2 + DDG9 Polyclonal Rabbit Anti-Human IgM/FITC, Rabbit F(ab')2 Monoclonal Mouse Anti-Human CD16, Fc Gamma Receptor III/RPE, Clone DJ130c Polyclonal Rabbit Anti-Human Protein S Monoclonal Mouse Anti-Human Myeloperoxidase/PerCP-Cy5.5, Clone MPO-7 MultiMix Dual-Colour Reagent, Anti-Human Kappa Light Chains/FITC + Anti-Human Lambda Light Chains/RPE Monoclonal Mouse Anti-Human CD25, Interleukin-2 Receptor/RPE, Clone ACT-1 Isotype Reagent, Mouse IgG2a/FITC IGH FISH DNA Probe, Split Signal Monoclonal Mouse Anti-Human CD23/RPE, Clone MHM6 Monoclonal Mouse Anti-Human Plasma Cell/FITC, Clone VS38c Monoclonal Mouse Anti-Human CD79cy/APC, Clone HM57 TCRG FISH DNA Probe, Split Signal Polyclonal Rabbit Anti-Human C1q Complement Monoclonal Mouse Anti-Human CD45, Leucocyte Common Antigen/RPE-Cy5, Clone T29/33 Monoclonal Mouse Anti-Human CD235a, Glycophorin A/FITC, Clone JC159 Monoclonal Mouse Anti-Human CD33/RPE, Clone WM-54 Monoclonal Mouse Anti-Human CD103, Mucosa Lymphocyte Antigen/RPE, Clone Ber-ACT8 Monoclonal Mouse Anti-Human CD10/RPE, Clone SS2/36 PAX5 FISH DNA Probe, Split Signal Monoclonal Mouse Anti-Human Epithelial Antigen/FITC, Clone Ber-EP4 Monoclonal Mouse Anti-Human CD5/FITC, Clone DK23 Monoclonal Mouse Anti-Human CD24/FITC, Clone SN3 IGK FISH DNA Probe, Split Signal Polyclonal Rabbit Anti-Hepatitis B Virus Core Antigen Monoclonal Mouse Anti-Human CD1a/RPE, Clone NA1/34 Monoclonal Mouse Anti-Human CD8/FITC, Clone DK25 BCL6 FISH DNA Probe, Split Signal Monoclonal Mouse Anti-Human CD7/PerCP-Cy5.5, Clone CBC.37 Monoclonal Mouse Anti-Human CD5/APC, Clone DK23 Rabbit Ig Reagent, F(ab')2/RPE Polyclonal Rabbit Anti-Helicobacter Pylori Polyclonal Rabbit Anti-Human IgM/RPE, Rabbit F(ab')2 Monoclonal Mouse Anti-Human CD64, Fc Gamma Receptor I/APC, Clone 10.1 ALK FISH DNA Probe, Split Signal Monoclonal Mouse Anti-Human CD7/FITC, clone CBC.37 Polyclonal Rabbit Anti-Human Kappa Light Chains/RPE, Rabbit F(ab')2 MYC FISH DNA Probe, Split Signal Monoclonal Mouse Anti-Human CD71, Transferrin Receptor/FITC, Clone Ber-T9 Polyclonal Rabbit Anti-Human Lysozyme EC 3.2.1.17/FITC Monoclonal Mouse Anti-Human CD41, Platelet Glycoprotein IIb/FITC, Clone 5B12 Polyclonal Rabbit Anti-Human Lambda Light Chains/RPE, Rabbit F(ab')2 Monoclonal Mouse Anti-Human CD45, Leucocyte Common Antigen/PerCP Clone 2D1 Fragile X Probe, Fluorescein Labelled MultiMix Dual-Colour Reagent, Anti-Human Kappa Light Chains/FITC + Anti-Human CD19/RPE Monoclonal Mouse Anti-Human HLA-DR Antigen/FITC, Clone AB3 MultiMix Triple-Colour Reagent, Anti-Human: Kappa Light Chains/FITC + Lambda Light Chains/RPE + CD19/RPE-Cy-5 Monoclonal Mouse Anti-Human CD34 Class III/APC, Clone BIRMA-K3 Polyclonal Rabbit Anti-Human c-erbB-2 Oncoprotein Monoclonal Mouse Anti-Human CD38/RPE, Clone AT13/5 Monoclonal Mouse Anti-Enterovirus, Clone 5-D8/1 Monoclonal Mouse Anti-Human Plasma Cell/PerCP-Cy5.5, clone Vs38c MultiMix" Triple-Colour Control Reagent, Rabbit F(ab')2/FITC + Rabbit F(ab')2/RPE + Mouse IgG1/RPE-Cy5 Monoclonal Mouse Anti-Human CD15/FITC, Clone C3D-1 Monoclonal Mouse Anti-Human CD5/RPE, Clone DK23 Isotype Reagent, Mouse IgG2a/RPE Monoclonal Mouse Anti-Human Ki-67 Antigen/FITC, Clone MIB-1 Monoclonal Mouse Anti-Human CD138/RPE, Clone MI15 Monoclonal Mouse Anti-Human CD42b, Platelet Glycoprotein Ib/RPE, Clone AN51 Monoclonal Mouse Anti-Epstein-Barr Virus, LMP, Clones CS.1-4 BCL3 FISH DNA Probe, Split Signal Polyclonal Rabbit Anti-Human Lambda/PerCP-Cy5.5 Polyclonal Rabbit Anti-Human IgG/FITC, Rabbit F(ab')2 Monoclonal Mouse Anti-Human B Cell/FITC, Clone FMC7 Monoclonal Mouse Anti-Human Myeloperoxidase/FITC, Clone MPO-7 BCL10 FISH DNA Probe, Split Signal Polyclonal Rabbit Anti-Parvovirus B19 Monoclonal Mouse Anti-Human CD2/RPE, Clone MT910 Rabbit Ig Reagent, F(ab')2/FITC Monoclonal Mouse Anti-Human Immunodeficiency Virus, p24, Clone Kal-1 TCRB FISH DNA Probe, Split Signal Monoclonal Mouse Anti-Human CD34 Class III/FITC, Clone BIRMA-K3 Polyclonal Rabbit Anti-Human IgD/FITC, Rabbit F(ab')2 Monoclonal Mouse Anti-Human CD19/APC, Clone HD37 Monoclonal Mouse Anti-Human CD90/FITC, Clone 5E10 Monoclonal Mouse Anti-Human CD7/RPE, clone CBC.37 Monoclonal Mouse Anti-Human CD19/PB, Clone HD37 Monoclonal Mouse Anti-Human CD103, Mucosa Lymphocyte Antigen/FITC, Clone Ber-ACT8 TLX1 FISH DNA Probe, Split Signal Monoclonal Mouse Anti-Human CD1a/FITC, Clone NA1/34 Monoclonal Mouse Anti-Human CD25, Interleukin-2 Receptor/FITC, Clone ACT-1 Monoclonal Mouse Anti-Human CD45R0/RPE, Clone UCHL1 Monoclonal Mouse Anti-Human HLA-DP, DQ, DR Antigen/FITC, Clone CR3/43 Monoclonal Mouse Anti-Human CD117, c-kit/APC, Clone 104D2 Monoclonal Mouse Anti-Human CD45, Leucocyte Common Antigen/PB, Clone T29/33 Monoclonal Mouse Anti-Human CD34 Class III/RPE, Clone BIRMA-K3 Monoclonal Mouse Anti-Human CD20/FITC, Clone B-Ly1 Monoclonal Mouse Anti-Human CD45RA/RPE, Clone 4KB5 MALT1 FISH DNA Probe, Split Signal Monoclonal Mouse Anti-Human CD79S/RPE, Clone SN8 MultiMix" Dual-Colour Control Reagent, Rabbit F(ab')2/FITC + Mouse IgG1/RPE Monoclonal Mouse Anti-Human CD41, Platelet Glycoprotein IIb/RPE, Clone 5B12 Monoclonal Mouse Anti-Human CD66abce/FITC, Clone Kat4c MultiMix" Triple-Colour Control Reagent, Mouse IgG1/FITC + Rabbit F(ab')2/RPE + Rabbit F(ab')2"/APC Monclonal Mouse Anti-Human CD235a, Glycophorin A/RPE, Clone JC159 Monoclonal Mouse Anti-Human HLA-ABC Antigen/RPE, Clone W6/32 Monoclonal Mouse Anti-Human CD117, c-kit/RPE, Clone 104D2 TCRAD FISH DNA Probe, Split Signal Monoclonal Mouse Anti-Human CD22/PerCP-Cy5.5, clone 4KB128 Monoclonal Mouse Anti-Human CD3/PerCP, Clone UCHT1 Monoclonal Mouse Anti-Human CD57/FITC, Clone TB01 Monoclonal Mouse Anti-Human Terminal Deoxynucleotidyl Transferase/FITC, Clone HT-6 Monoclonal Mouse Anti-Human CD19/PerCP-Cy Monoclonal Mouse Anti-Human CD34/PerCP-Cy5.5, Clone BIRMA-K3 Monoclonal Mouse Anti-Human HLA-DR Antigen/RPE, Clone AB3 Rabbit Ig Reagent, F(ab')2/APC Polyclonal Rabbit Anti-Human Kappa Light Chains/APC, Rabbit F(ab')2 Monoclonal Mouse Anti-Human Myeloperoxidase/APC, Clone MPO-7 Monoclonal Mouse Anti-Human Papillomavirus (HPV), Clone K1H8 Monoclonal Mouse Anti-Human CD20/RPE, Clone B-Ly1 TCL1 FISH DNA Probe, Split Signal Monoclonal Mouse Anti-Human CD61, Platelet Glycoprotein IIIa/APC, Clone Y2/51 Monoclonal Mouse Anti-Human CD61, Platelet Glycoprotein IIIa/FITC, Clone Y2/51 Polyclonal Rabbit Anti-Human IgD Monoclonal Mouse Anti-Human BCL2 Oncoprotein/FITC, Clone 124 Monoclonal Mouse Anti-Human CD45, Leucocyte Common Antigen/APC, Clone T29/33 Monoclonal Mouse Anti-Human CD33/FITC, Clone WM-54 Monoclonal Mouse Anti-Human CD79cy/RPE, Clone HM57 Monoclonal Rabbit Anti-Human Akt-pS473, Phosphorylation Site Specific, Clone 14-5 Monoclonal Mouse Anti-Human CD38/FITC, Clone AT13/5 CCND1 FISH DNA Probe, Split Signal Isotype Reagent, Mouse IgG2b/FITC MultiMix Triple-Colour Reagent, Anti-Human CD19/FITC + Anti-Human Lambda Light Chains/RPE + Anti-Human Kappa Light Chain Monoclonal Mouse Anti-Human CD30/FITC, Clone Ber-H2 Monoclonal Mouse Anti-Human Myeloperoxidase/RPE, Clone MPO-7 Monoclonal Mouse Anti-Human PD-L1 Clone 22C3 Monoclonal Mouse Anti-Human CD64, Fc Gamma Receptor I/RPE, Clone 10.1 Monoclonal Mouse Anti-Human CD19/FITC, Clone HD37 Monoclonal Mouse Anti-Human CD8/APC, Clone DK25 Monoclonal Mouse Anti-Human CD45, Leucocyte Common Antigen/FITC, Clone T29/33 Monoclonal Mouse Anti-Human CD19/PerCP-Cy5.5, Clone HD37 Monoclonal Mouse Anti-Human CD10/FITC, Clone SS2/36 Monoclonal Mouse Anti-Human CD22/RPE, Clone 4KB128 SureFISH 28S rRNA CISH Probe Kappa mRNA CISH Probe Monoclonal Mouse Anti-Human CD14/FITC, Clone TUK4 Monoclonal Mouse Anti-Human CD14/RPE, Clone TUK4 EBER RNA CISH Probe Lambda mRNA CISH Probe Monoclonal Mouse Anti-Human CD45, Leucocyte Common Antigen/RPE, Clone T29/33 Monoclonal Mouse Anti-Human Terminal Deoxynucleotidyl Transferase/iFluor 488, Clone DAK-TDT Monoclonal Mouse Anti-Human Terminal Deoxynucleotidyl Transferase/APC, Clone DAK-TDT Monoclonal Mouse Anti-Human Terminal Deoxynucleotidyl Transferase/iFluor 700, Clone DAK-TDT Polyclonal Rabbit Anti-Human Fibrinogen/FITC Polyclonal Rabbit Anti-Human IgA Dako PT Link Pascal Hybridizer PT Link Dako PT Link (PT200) Pascal Quality Strips Hybridizer Humidity Control Strips Polyclonal Rabbit Anti-Human Alpha-1-Antitrypsin Monoclonal Mouse Anti-Human CD8/RPE, Clone DK25 Polyclonal Rabbit Anti-Human IgM

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MVD System, Test, Her-2/Neu, Nucleic Acid Or Serum Unknown Class 3 N/A 2020-12-16
GKZ Counter, Differential Cell Hematology Class 2 864.5220 2020-10-06
GKZ Counter, Differential Cell Hematology Class 2 864.5220 2020-10-06
GKZ Counter, Differential Cell Hematology Class 2 864.5220 2020-10-06
GKZ Counter, Differential Cell Hematology Class 2 864.5220 2020-10-06
GKZ Counter, Differential Cell Hematology Class 2 864.5220 2020-10-06
GKZ Counter, Differential Cell Hematology Class 2 864.5220 2020-10-06
DEO Kappa, Fitc, Antigen, Antiserum, Control Immunology Class 2 866.5550 2020-09-25
PPM General Purpose Reagent Pathology Class 1 864.4010 2014-11-25
CZN Iga, Fitc, Antigen, Antiserum, Control Immunology Class 2 866.5510 2020-09-25
JMR Immunochemical, Lysozyme (Muramidase) Clinical Chemistry Class 1 862.1490 2020-09-23
MXZ Immunohistochemistry Assay, Antibody, Progesterone Receptor Hematology Class 2 864.1860 2020-09-25
DEH Lambda, Antigen, Antiserum, Control Immunology Class 2 866.5550 2020-09-25
CZW Complement C3, Antigen, Antiserum, Control Immunology Class 2 866.5240 2020-09-25
KPA Slide Stainer, Automated Pathology Class 1 864.3800 2018-11-09
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2020-09-25
NDY Test, Cystatin C Clinical Chemistry Class 2 862.1225 2020-09-25
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2020-09-25
GKZ Counter, Differential Cell Hematology Class 2 864.5220 2020-10-06
KEW Slides, Microscope Pathology Class 1 864.3010 2020-09-23
DFS Igm, Fitc, Antigen, Antiserum, Control Immunology Class 2 866.5550 2020-09-25
DBI Complement C4, Antigen, Antiserum, Control Immunology Class 2 866.5240 2020-09-25
DEW Igg, Antigen, Antiserum, Control Immunology Class 2 866.5510 2020-09-25
HYJ Hematoxylin Hematology Class 1 864.1850 2020-09-23
GGK Products, Red-Cell Lysing Products Hematology Class 1 864.8540 2020-09-23
KES Coverslips, Microscope Slide Pathology Class 1 864.3010 2020-09-24
OUG Medical Device Data System General Hospital Class 1 880.6310 2020-09-24
MVC System, Test, Her-2/Neu, Ihc Unknown Class 3 N/A 2020-10-06
KEM Agent, Clearing Pathology Class 1 864.4010 2020-09-24
DES Lambda, Fitc, Antigen, Antiserum, Control Immunology Class 2 866.5550 2020-09-25
GKZ Counter, Differential Cell Hematology Class 2 864.5220 2020-10-06
DGK Igg, Fitc, Antigen, Antiserum, Control Immunology Class 2 866.5510 2020-09-25
MVU Reagents, Specific, Analyte Pathology Class 1 864.4020 2014-11-25
CZP Iga, Antigen, Antiserum, Control Immunology Class 2 866.5510 2020-09-25
LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use Clinical Chemistry Class 1 862.2050 2016-01-22
DEW Igg, Antigen, Antiserum, Control Immunology Class 2 866.5510 2020-09-25
GKZ Counter, Differential Cell Hematology Class 2 864.5220 2020-10-06
DAO Igm (Mu Chain Specific), Antigen, Antiserum, Control Immunology Class 2 866.5550 2020-09-25

Official Correspondent

Widad Ghaben

US Agent Details

Widad Ghaben Business: Agilent Technologies Inc. Email: enterprise.regulatory@agilent.com Phone: (408) 5537305

Related Public Records

Same Entity

Agilent Technologies, Inc
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Other Registrations for Same Entity

Registration Number Establishment Name Location
3005716001 Agilent Technologies LDA Penang Pulau Pinang, MY
3009202467 Agilent Technologies Waldbronn Baden-Wurttemberg, DE
3013059683 ATSI Logistics Center ApS GLOSTRUP Hovedstaden, DK
1217454 Agilent Technologies, Inc. Winooski, VT, US
3003423869 Agilent Technologies Singapore (International) Pte Ltd. Singapore North East, SG

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K832257 Gelco Diagnostics, Inc. GOAT ANTI-HUMAN IGA A CHAIN SPECIFIC 1983-10-28
K882259 Diagnostic Chemicals, Ltd. (Usa) DC-BILITROL CATALOGUE # SE-021, SE-022, SE-023 1988-07-21
K060322 Cliniqa Corporation CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED 2006-03-21

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0002-05 ABX Diagnostics Inc 2
Automated Differential Cell Counter
Z-0003-05 ABX Diagnostics Inc 2
Automated Differential Cell Counter
Z-0011-2014 Siemens Healthcare Diagnostics 2
ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162 and SMN 10361798 --- CLASSIFICATION NAME: Counter, Differential Cell, Automated (Particle Counter) The ADVIA 2120/2120i are hematology systems that utilizes the principles of flow cytometry in order to provide complete blood counts.
Z-0021-2013 Beckman Coulter Inc. 2
Unicel DxH 800 Coulter Cellular Analysis System, Part Number 629029. The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides a: " Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood. " Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF).
Z-0033-2013 Beckman Coulter Inc. 2
CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number 6607013. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/ CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5.

Similar Registrations

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3013059683 ATSI Logistics Center ApS GLOSTRUP Hovedstaden, DK
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3009189893 Agilent Technologies Inc. Cedar Creek, TX, US
3009297077 Diatron MI Plc Budapest, HU
3027394506 Becton, Dickinson and Company, BD Biosciences Milpitas, CA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9610099. Last updated year: 2026. Please use registration number 9610099 when referencing this establishment in official correspondence.
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