Agilent Technologies Inc.

FDA Device Registration & Listing · Cedar Creek, TX, US · Registration 3009189893

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
3009189893
FEI Number
3009189893
Entity Name
Agilent Technologies Inc.
City/State/Country
Cedar Creek, TX, US
Establishment Address
1834 State Highway 71 West, Cedar Creek, TX 78612, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
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

Artisan Mucicarmine Stain Kit Artisan Alpha-Amylase Clearify Polyclonal Rabbit Anti-Human Prealbumin Polyclonal Rabbit Anti-Human IgG/FITC Polyclonal Rabbit Anti-Human Retinol-Binding Protein Polyclonal Rabbit Anti-Human Serum Monoclonal Mouse Anti-Human CD3/RPE-Cy5, Clone UCHT1 Monoclonal Mouse Anti-Human CD3/RPE, Clone UCHT1 Artisan Jenner-Wright Giemsa Stain Kit Artisan Giemsa Stain Kit Negative Control, Mouse IgG1/RPE-Cy5 Negative Control, Mouse IgG1/FITC Negative Control, Mouse IgG1/RPE Monoclonal Mouse Anti-Human CD19/RPE-Cy5, Clone HD37 Artisan Colloidal Iron Stain Kit MultiMix Dual-Colour Reagent, Anti-Human CD3/FITC + Anti-Human CD19/RPE Monoclonal Mouse Anti-Human CD8/RPE, Clone DK25 MultiMix Dual-Colour Reagent, Anti-Human CD4/FITC + Anti-Human CD8/RPE Methyl Green, Counterstain Artisan Iron Stain Kit Polyclonal Rabbit Anti-Human Kappa Light Chains Ulisa 6.1x ULISA 6.2x Polyclonal Rabbit Anti-Human IgM/FITC Artisan Gram Yellow Stain Kit Artisan Gram Stain Kit FLEX Monoclonal Mouse Anti-Human CD56, Clone 123C3, Ready-to-Use (Dako Omnis) FLEX Monoclonal Mouse Anti-Human Calretinin, Clone DAK-Calret 1, Ready-to-Use (Dako Omnis) FLEX Monoclonal Mouse Anti-Human BCL2 Oncoprotein, Clone 124, Ready-to-Use (Dako Omnis) FLEX Polyclonal Rabbit Anti-Human Alpha-1-Fetoprotein, Ready-to-Use (Dako Omnis) FLEX Monoclonal Mouse Anti-Human Desmin, Clone D33, Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Human Cytokeratin 7, Clone OV-TL 12/30, Ready-to-Use (Dako Omnis) Polyclonal Rabbit Anti-Laminin FLEX Monoclonal Mouse Anti-Human Ki-67 Antigen, Clone MIB-1, Ready-to-Use (Dako Autostainer/Autostainer Plus) FLEX Monoclonal Rabbit Anti-Human AMACR, Clone 13H4 Ready-to-Use (Dako Omnis) Polyclonal Rabbit Anti-Human Somatostatin Negative Control, Mouse IgG1 FLEX Polyclonal Rabbit Anti-Human Chorionic Gonadotropin, Ready-to-Use (Dako Autostainer/Autostainer Plus) Polyclonal Rabbit Anti-Human IgG/FITC, Rabbit F(ab')2 FLEX Monoclonal Mouse Anti-Vimentin, Clone V9, Ready-to-Use (Dako Autostainer/Autostainer Plus) Monoclonal Rabbit Anti-Human PMS2 EP51, Ready-to-Use (Link) Monoclonal Mouse Anti-Human HLA-ABC Antigen, Clone W6/32 FLEX Monoclonal Rabbit Anti-Human P504S, Clone 13H4, Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Human CD5, Clone 4C7, Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Human Smooth Muscle Actin, Clone 1A4, Ready-to-Use (Dako Autostainer/Autostainer Plus) FLEX Monoclonal Rabbit Anti-Human Postmeiotic Segregation Increased 2, Clone EP51, Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Human E-Cadherin, Clone NCH-38, Ready-to-Use (Dako Omnis) FLEX Monoclonal Mouse Anti-Human Cytokeratin, Clone AE1/AE3, Ready-to-Use (Dako Omnis) DuoFLEX Cocktail Anti-CD3 Anti-CD20cy, Ready-do-Use (Dako Autostainer/Autostainer Plus) FLEX Monoclonal Mouse Anti-Human Prostate Specific Membrane Antigen (PSMA), Clone 3E6, Ready-to-use (Link) Negative Control, Mouse IgM Polyclonal Rabbit Anti-Human IgM FLEX Monoclonal Mouse Anti-Human CA 125 Clone M11, Ready-to-Use (Dako Autostainer/Autostainer Plus) Monoclonal Mouse Anti-Human Leukaemia, Hairy Cell, Clone DBA.44 FLEX Monoclonal Mouse Anti-Human Nucleophosmin, Clone 376, Ready-to-Use (Dako Omnis) FLEX Monoclonal Mouse Anti-Human CD4, Clone 4B12, Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Human CD31, Endothelial Cell, Clone JC70A, Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Human CD31, Endothelial Cell, Clone JC70A, Ready-to-Use (Dako Omnis) Monoclonal Rabbit Anti-Human Postmeiotic Segregation Increased 2, Clone EP51 Monoclonal Mouse Anti-Human Epithelial Antigen, Clone Ber-EP4 FLEX Monoclonal Mouse Anti-Human MutL Protein Homolog 1, Clone ES05, Ready-to-Use (Link) FLEX Polyclonal Rabbit Anti-Human Von Willebrand Factor Antigen, Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Human Muscle Actin, Clone HHF35, Ready-to-Use (Dako Autostainer/Autostainer Plus) FLEX Monoclonal Mouse Anti-Human BCL6 Protein, Clone PG-B6p, Ready-to-Use (Dako Autostainer/Autostainer Plus) Monoclonal Mouse Anti-Human IMP3, Clone 69.1 Negative Control, Mouse IgG2a FLEX Monoclonal Mouse Anti-Human ERCC1, Clone 4F9, Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Human Ki-67 Antigen, Clone MIB-1, Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Human CD34 Class 2, Clone QBEnd 10, Ready-to-Use (Dako Omnis) FLEX Monoclonal Mouse Anti-Human CD5, Clone 4C7 Ready-to-Use (Dako Autostainer/Autostainer Plus) Polyclonal Rabbit Anti-Human Thyroglobulin Monoclonal Rabbit Anti-Human MutS Protein Homolog 6, Clone EP49 FLEX Monoclonal Mouse Anti-Human Cytokeratin High Molecular Weight, Clone 34BE12, Ready-to-Use (Dako Omnis) Monoclonal Mouse Anti-Human COX-2, Clone CX-294 Monoclonal Mouse Anti-Human CD14, Clone TUK4 Monoclonal Mouse Anti-Human Topoisomerase IIalpha, Clone Ki-S1 Monoclonal Mouse Anti-Human Melanosome, Clone HMB-45 FLEX Polyclonal Rabbit Anti-Human IgG, Ready-to-Use (Dako Autostainer/Autostainer Plus) FLEX Monoclonal Mouse Anti-Human Inhibin , Clone R1, Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Human CD21, Clone 1F8, Ready-to-Use (Link) Monoclonal Mouse Anti-Human CD35, Clone Ber-MAC-DRC FLEX Monoclonal Mouse Anti-Human CD79 alpha, Clone JCB117, Ready-to-Use (Dako Autostainer/Autostainer Plus) Monoclonal Mouse Anti-Human MyoD1, Clone 5.8A FLEX Polyclonal Rabbit Anti-Human Prostate Specific Antigen, Ready-to-Use (Dako Autostainer/Autostainer Plus) FLEX Monoclonal Mouse Anti-Human Cytokeratin 5/6, Clone D5/16 B4, Ready-to-Use (Link) Monoclonal Mouse Anti-Human Mast Cell Tryptase, Clone AA1 FLEX Monoclonal Mouse Anti-Human CD23, Clone DAK-CD23, Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Human Melanosome, Clone HMB45 Ready-to-Use (Link) Monoclonal Mouse Anti-Human CD34 Class II, Clone QBEnd 10 Monoclonal Mouse Anti-Human Survivin, Clone 12C4 FLEX Polyclonal Rabbit Anti-Human Myeloperoxidase, Ready-to-Use (Dako Omnis) Monoclonal Mouse Anti-Human Cytokeratin 5/6, Clone D5/16 B4 FLEX Monoclonal Mouse Anti-Human CD10, Clone 56C6, Ready-to-Use (Link) Monoclonal Mouse Anti-Human Neuron-Specific Enolase, Clone BBS/NC/VI-H14 Monoclonal Mouse Anti-Human Calretinin, Clone DAK-Calret 1 FLEX Monoclonal Mouse Anti-Human Cytokeratin 19, Clone RCK108, Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Human CD68, Clone KP1, Ready-to-Use (Dako Autostainer/Autostainer Plus) FLEX Monoclonal Mouse Anti-Human Neuron-Specific Enolase, Clone BBS/NC/VI-H14, Ready-to-Use (Link) FLEX Polyclonal Rabbit Anti-Human Prostate-Specific Antigen, Ready-to-Use (Dako Omnis) FLEX Monoclonal Mouse Anti-Cytokeratin 17, Clone E3, Ready-to-Use (Dako Autostainer/Autostainer Plus) FLEX Monoclonal Mouse Anti-Human Mast Cell Tryptase, Clone AA1, Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Human Cytokeratin 7, Clone OV-TL 12/30, Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Human CD79, Clone JCB117, Ready-to-Use (Dako Omnis) FLEX Monoclonal Mouse Anti-Human Cytokeratin 20, Clone Ks20.8, Ready-to-Use (Dako Omnis) Monoclonal Mouse Anti-CA 19-9, Clone 116-NS-19-9 Monoclonal Rabbit Anti-Human AMACR, Clone 13H4 FLEX Monoclonal Mouse anti-human CD56, Clone 123C3, Ready-to-Use (Link) FLEX Polyclonal Rabbit Anti-Human Chorionic Gonadotropin, Ready-to-Use (Dako Omnis) FLEX Monoclonal Mouse Anti-Human CA 125 Clone M11, Ready-to-Use (Link) Monoclonal Mouse Anti-Human CD57, Clone TB01 Polyclonal Rabbit Anti-Human Myeloperoxidase FLEX Monoclonal Mouse Anti-Human Tyrosinase, Clone T311, Ready-to-Use (Dako Autostainer/Autostainer Plus) FLEX Polyclonal Rabbit Anti-Human CD3, Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Human Caldesmon, Clone h-CD, Ready-to-Use (Dako Autostainer/Autostainer Plus) FLEX Monoclonal Mouse Anti-Human Ki-67 Antigen, Clone MIB-1, Ready-to-use (Dako Omnis) FLEX Monoclonal Mouse Anti-Human Nucleophosmin, Clone 376, Ready-to-Use (Dako Autostainer/Autostainer Plus) FLEX Monoclonal Rabbit Anti-Human Cyclin D1, Clone EP12, Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Human CD7, Clone CBC.37, Ready-to-Use (Dako Autostainer/Autostainer Plus) FLEX Monoclonal Mouse Anti-Human Cytokeratin 18, Clone DC 10, Ready-to-Use (Dako Omnis) Monoclonal Mouse Anti-Human Laminin, Clone 4C7 Monoclonal Mouse Anti-Human Melan-A, Clone A103 FLEX Monoclonal Mouse Anti-Human Hepatocyte, Clone OCH1E5, Ready-to-Use (Dako Omnis) FLEX Monoclonal Mouse Anti-Human B-cell Specific Activator Protein, Clone DAK-PAX5, Ready-to-Use (Dako AS/AS+) Monoclonal Mouse Anti-Human MutL Protein Homolog 1, Clone ES05 FLEX Polyclonal Rabbit Anti-Human Alpha-1-Fetoprotein, Ready-to-Use (Dako Autostainer/Autostainer Plus) Monoclonal Mouse Anti-Human BCL2 Oncoprotein, Clone 124 Monoclonal Mouse Anti-Human Thymidylate Synthase, Clone TS106 Monoclonal Mouse Anti-Rabbit Immunoglobulins, Clone MR12/53 FLEX Monoclonal Mouse Anti-Human CD8, Clone C8/144B, Ready-to-Use (Link) Monoclonal Mouse Anti-Human Hepatocyte, Clone OCH1E5 FLEX Monoclonal Mouse Anti-Human Wilms Tumor 1 Protein, Clone 6F-H2 Ready-to-Use (Dako Autostainer/Autostainer Plus) Monoclonal Mouse Anti-Thyroid Transcription Factor, Clone 8G7G3/1 Polyclonal Rabbit Anti-Human Calcitonin FLEX Monoclonal Mouse Anti-Human Mast Cell Tryptase, Clone AA1, Ready-to-Use (Dako Autostainer/Autostainer Plus) FLEX Monoclonal Mouse Anti-Human Epithelial Membrane Antigen, Clone E29, Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Human MutL Protein Homolog 1, Clone ES05, Ready-to-use (Dako Autostainer/Autostainer Plus) FLEX Polyclonal Guinea Pig Anti-Insulin, Ready-to-Use (Dako Autostainer/Autostainer Plus) Monoclonal Mouse Anti-Vimentin, Clone V9 Negative Control, Mouse IgG2b FLEX Monoclonal Rabbit Anti-Human ERG, Clone EP111, Ready-to-Use (Link) Monoclonal Mouse Anti-Human Laminin-5, Gamma-2 Chain, Clone 4G1 Monoclonal Mouse Anti-Human B-Cell Specific Activator Protein, Clone DAK-Pax5 FLEX Monoclonal Mouse Anti-Human CDX2, Clone DAK-CDX2, Ready-to-use (Link) Monoclonal Mouse Anti-Human CD246, ALK Protein, Clone ALK1 Polyclonal Rabbit Anti-Human Myelin Basic Protein FLEX Monoclonal Mouse Anti-Human CD15, Clone Carb-3, Ready-to-Use (Dako Omnis) FLEX Monoclonal Mouse Anti-Human CD138, Clone MI15, Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Human Caldesmon, Clone h-CD, Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Human CD43, Clone DF-T1, Ready-to-Use (Dako Omnis) FLEX Monoclonal Mouse Anti-Human Beta-Catenin, Clone beta-Catenin-1, Ready-to-Use (Dako Omnis) FLEX Monoclonal Mouse Anti-Human Vimentin, Clone V9, Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Myogenin, Clone F5D, Ready-to-Use (Dako Omnis) Monoclonal Mouse Anti-Human Prostatic Acid Phosphatase, Clone PASE/4LJ Monoclonal Mouse Anti-Human Beta-Amyloid, Clone 6F/3D FLEX Monoclonal Mouse Anti-Human E-Cadherin, Clone NCH-38, Ready-to-Use (Dako Autostainer/Autostainer Plus) FLEX Monoclonal Mouse Anti-Human Gross Cystic Disease Fluid Protein-15, Clone 23A3, Ready-to-Use (Dako Omnis) FLEX Monoclonal Mouse Anti-Human Melanosome, Clone HMB45, Ready-to-Use (Dako Autostainer/Autostainer Plus) FLEX Monoclonal Rabbit Anti-Human Cytokeratin 8/18, Clone EP17/EP30, Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Human Cytokeratin, High Molecular Weight, Clone 34BetaE12, Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Human BCL6 Protein, Clone PG-B6p, Ready-to-Use (Dako Omnis) FLEX Monoclonal Mouse Anti-Human CD99, MIC2 Gene Product Ewing's Sarcoma Marker, Clone 12E7, RTU (Link) FLEX Polyclonal Rabbit Anti-Human IgA, Ready-to-Use (Dako Omnis) FLEX Monoclonal Mouse Anti-Human CD19, Clone LE-CD19, Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Human CD2, Clone AB75, Ready-to-Use (Dako Omnis) Monoclonal Rabbit Anti-Human Cytokeratin 8/18, Clone EP17/EP30 FLEX Polyclonal Rabbit Anti-Human Lambda Light Chains, Ready-to-Use (Dako Autostainer/Autostainer Plus) FLEX Universal Negative Control, Mouse, Ready-to-Use (Dako Autostainer/Autostainer Plus) Monoclonal Mouse Anti-Human CD3, Clone F7.2.38 FLEX Monoclonal Mouse Anti-Myogenin, Clone F5D, Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Human Cytokeratin, High Molecular Weight, Clone 34BE12, RTU (Dako Autostainer) Monoclonal Mouse Anti-Human Gross Cystic Disease Fluid Protein-15, Clone 23A3 Monoclonal Mouse Anti-Human Prostate-Specific Antigen, Clone ER-PR8 FLEX Monoclonal Mouse Anti-Human MUC2, Clone CCP58, Ready-to-Use (Link) FLEX Monoclonal Rabbit Anti-Human Terminal Deoxynucleotidyl Transferase, Clone EP266 Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Human Cytokeratin 18, Clone DC 10, Ready-to-Use (Dako Autostainer/Autostainer Plus) Monoclonal Mouse Anti-Human CD30, Clone Ber-H2 FLEX Monoclonal Mouse Anti-Cytokeratin 17, Clone E3, Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Human Neurofilament Protein, Clone 2F11, Ready-to-Use (Dako Omnis) FLEX Polyclonal Rabbit Anti-Human Von Willebrand Factor, Ready-to-Use (Dako Omnis) FLEX Polyclonal Rabbit Anti-Human IgM, Ready-to-Use (Dako Autostainer/Autostainer Plus) Monoclonal Mouse Anti-Human Muscle Actin, Clone HHF35 Monoclonal Mouse Anti-Human Mammaglobin, Clone 304-1A5 FLEX Monoclonal Mouse Anti-Human Placental Alkaline Phosphatase, Clone 8A9, RTU (Dako Autostainer/Autostainer Plus) Monoclonal Mouse Anti-Human CDX2, Clone Dak-CDX2 FLEX Monoclonal Mouse Anti-Villin, Clone 1D2 C3, Ready-to-Use (Dako Autostainer/Autostainer Plus) Monoclonal Mouse Anti-Human Luteinizing Hormone (LH), Clone C93 FLEX Monoclonal Mouse Anti-Human Desmin, Clone D33, Ready-to-Use (Dako Autostainer/Autostainer Plus) Monoclonal Mouse Anti-Human Chromogranin A, Clone DAK-A3 FLEX Monoclonal Mouse Anti-Human E-Cadherin, Clone NCH-38, Ready-to-Use (Link) FLEX Polyclonal Rabbit Anti-Human Chorionic Gonadotropin, Ready-to-Use (Link) FLEX Polyclonal Rabbit Anti-Human IgM, Ready-to-Use (Link) Polyclonal Rabbit Anti-Human Prolactin FLEX Polyclonal Rabbit Anti-S100, Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Human Cytokeratin 5/6, Clone D5/16 B4, Ready-to-Use (Dako Autostainer/Autostainer Plus) Monoclonal Mouse Anti-Human CD20cy, Clone L26 FLEX Monoclonal Mouse Anti-Human Neuron-Specific Enolase, Clone BBS/NC/VI-H14, Ready-to-Use (Dako Autostainer) Monoclonal Mouse Anti-Adrenocorticotropin (ACTH), Clone 02A3 FLEX Monoclonal Mouse Anti-Human Epithelial Antigen, Clone Ber-EP4, Ready-to-Use (Dako Autostainer/Autostainer Plus) FLEX Monoclonal Mouse Anti-Thyroid Transcription Factor, Clone 8G7G3/1, Ready-to-Use (Link) Monoclonal Mouse Anti-Vimentin, Clone Vim 3B4 FLEX Monoclonal Mouse Anti-Human CD7, Clone CBC.37, Ready-to-Use (Link) Monoclonal Mouse Anti-Human Cytokeratin, Clone MNF116 FLEX Monoclonal Mouse Anti-Human Cytokeratin 19, Clone RCK108, Ready-to-Use (Dako Omnis) FLEX Monoclonal Mouse Anti-Synaptophysin, Clone SY38, Ready-to-Use (Dako Autostainer/Autostainer Plus) FLEX Monoclonal Mouse Anti-Human CD7, Clone CBC.37, Ready-to-Use (Dako Omnis) FLEX Monoclonal Mouse Anti-Human CD246, ALK Protein, Clone ALK1, Ready-to-Use (Dako Autostainer/Autostainer Plus) Monoclonal Mouse Anti-Human CD5, Clone 4C7 FLEX Monoclonal Mouse Anti-Human Muscle Actin, Clone HHF35, Ready-to-Use (Link) Monoclonal Rabbit Anti-Human p53, Clone 318-6-11 FLEX Monoclonal Mouse Anti-Human Smooth Muscle Actin, Clone 1A4, Ready-to-Use (Dako Omnis) FLEX Monoclonal Mouse Anti-Human Hepatocyte, Clone OCH1E5, Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Human CD21, Clone 1F8, Ready-to-Use (Dako Autostainer/Autostainer Plus) FLEX Monoclonal Mouse Anti-Human CD30, Clone Ber-H2, Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Human CD34, Clone QBEnd 10, Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Human Beta-Catenin, Clone beta-Catenin-1, Ready-to-Use (Dako Autostainer/Autostainer Plus) FLEX Monoclonal Mouse Anti-Human Neurofilament Protein, Clone 2F11, Ready-to-Use (Dako Autostainer/Autostainer Plus) FLEX Monoclonal Mouse Anti-Human MutL Protein Homolog 1, Clone ES05, Ready-to-Use (Dako Autostainer) FLEX Monoclonal Mouse Anti-Human Cytokeratin, Clone AE1/AE3, Ready-to-Use (Link) Monoclonal Mouse Anti-Human Thyroglobulin, Clone DAK-Tg6 FLEX Monoclonal Mouse Anti-Human BCL6 Protein, Clone PG-B6p, Ready-to-Use (Link) FLEX Monoclonal Mouse, Anti-Human Caldesmon, Clone h-CD, Ready-to-Use (Dako Omnis) FLEX Polyclonal Rabbit Anti-Human CD3, Ready-to-Use (Dako Autostainer/Autostainer Plus) FLEX Monoclonal Mouse Anti-Human Mammaglobin, Clone 304-1A5, Ready-to-use (Link) Monoclonal Mouse Anti-Human CD7, Clone CBC.37 FLEX Monoclonal Mouse Anti-Human CD99, MIC2 Gene Product Ewing's Sarcoma Marker, Clone 12E7, RTU (Dako Autostainer) FLEX Monoclonal Mouse Anti-Human BCL2 Oncoprotein, Clone 124, Ready-to-Use (Dako Autostainer/Autostainer Plus) FLEX Monoclonal Mouse Anti-Human Cytokeratin, High Molecular Weight, Clone 34BetaE12, RTU (Dako Autostainer) FLEX Monoclonal Mouse Anti-Human CD57, Clone TB01, Ready-to-Use (Dako Omnis) Monoclonal Mouse Anti-Human Smooth Muscle Actin, Clone 1A4 Monoclonal Mouse Anti-Thrombomodulin, Clone 1009 Monoclonal Mouse Anti-Human Granzyme B, Clone GrB-7 FLEX Polyclonal Rabbit Anti-Human Calcitonin, Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Human CD15, Clone Carb-3, Ready-to-Use (Link) Monoclonal Mouse Anti-Human CD19, Clone LE-CD19 FLEX Monoclonal Mouse Anti-Human CD2, Clone AB75, Ready-to-Use (Dako Autostainer/Autostainer Plus) FLEX Monoclonal Rabbit Anti-Human MSH6 EP49, Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Human Melan-A, Clone A103, Ready-to-Use (Link) Polyclonal Rabbit Anti-Human IgG FLEX Monoclonal Mouse Anti-Human CD246, ALK Protein, Clone ALK1, Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Human CA 125, Clone M11, Ready-to-Use (Dako Omnis) FLEX Monoclonal Rabbit Anti-Human MutS Protein Homolog 6, Clone EP49, Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Human Cytokeratin 20, Clone Ks20.8, Ready-to-Use (Dako Autostainer/Autostainer Plus) FLEX Polyclonal Rabbit Anti-Human Kappa Light Chains, Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Human CD246, ALK Protein, Clone ALK1, Ready-to-Use (Dako Omnis) Polyclonal Rabbit Anti-Human CD117, c-kit Monoclonal Mouse Anti-Human CD23, Clone MHM6 Monoclonal Mouse Anti-Human C5b-9, Clone aE11 FLEX Polyclonal Rabbit Anti-Human Myeloperoxidase, Ready-to-Use (Link) FLEX Universal Negative Control, Rabbit, Ready-to-Use (Dako Autostainer/Autostainer Plus) Monoclonal Mouse Anti-Human MUC2, Clone CCP58 Monoclonal Mouse Anti-Human Thyroid-Stimulating Hormone (TSH), Clone 0042 Monoclonal Mouse Anti-Human CD235a, Glycophorin A, Clone JC159 FLEX Monoclonal Mouse Anti-Human Cytokeratin 5/6, Clone D5/16 B4, Ready-to-Use (Dako Omnis) FLEX Monoclonal Mouse Anti-human CD56, Clone 123C3, Ready-to-Use (Dako Autostainer/Autostainer Plus) Monoclonal Mouse Anti-Human Amyloid A, Clone mc1 Monoclonal Mouse Anti-Human p21WAF1/Cip1, Clone SX118 LEX Monoclonal Mouse Anti-Human CDX2, Clone DAK-CDX2, Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Vimentin, Clone V9, Ready-to-Use (Dako Omnis) Polyclonal Rabbit Anti-Human Growth Hormone Monoclonal Mouse Anti-Human Thyroid Peroxidase, Clone MoAb47 Monoclonal Mouse Anti-Villin, Clone 1D2 C3 Monoclonal Mouse Anti-Human Von Willebrand Factor, Clone F8/86 FLEX Monoclonal Mouse Anti-Human Hepatocyte, Clone OCH1E5, Ready-to-Use (Dako Autostainer/Autostainer Plus) FLEX Monoclonal Mouse Anti-Human Carcinoembryonic Antigen, Clone II-7, Ready-to-Use (Dako Autostainer/Autostainer Plus) Monoclonal Mouse Anti-Human Octamer-binding Transcription Factor 3/4 (Oct3/4), Clone N1NK Monoclonal Mouse Anti-Human Desmin, Clone D33 FLEX Monoclonal Mouse Anti-Human CD19, Clone LE-CD19, Ready-to-Use (Dako Autostainer/Autostainer Plus) FLEX Monoclonal Mouse Anti-Human Renal Cell Carcinoma Marker, Clone SPM314, Ready-to-Use (Dako Autostainer) FLEX Monoclonal Mouse Anti-Human Octamer-binding Transcription Factor 3/4, Clone N1NK, Ready-to-Use (Link) FLEX Polyclonal Rabbit Anti-Human IgD, Ready-to-Use (Link) Monoclonal Mouse Anti-Human PTEN, Clone 6H2.1 Monoclonal Rabbit Anti-Human CD15 Clone Carb-3 FLEX Polyclonal Rabbit Anti-Human Kappa Light Chains, Ready-to-Use (Dako Autostainer/Autostainer Plus) FLEX Monoclonal Mouse Anti-Villin, Clone 1D2 C3, Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Human CD57, Clone TB01, Ready-to-Use (Dako Autostainer/Autostainer Plus) Monoclonal Mouse Anti-Human E-Cadherin, Clone NCH-38 FLEX Monoclonal Mouse Anti-Human CD4, Clone 4B12, Ready-to-Use (Dako Autostainer/Autostainer Plus) Monoclonal Mouse Anti-Human Ki-67 Antigen, Clone MIB-1 FLEX Universal Negative Control, Mouse, Ready-to-Use (Dako Omnis) FLEX Monoclonal Mouse Anti-Human Synaptophysin, Clone DAK-SYNAP, Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Human Wilms Tumor 1 Protein, Clone 6F-H2, Ready-to-Use (Link) FLEX Polyclonal Rabbit Anti-Human IgG, Ready-to-Use (Dako Omnis) FLEX Monoclonal Mouse Anti-Human Smooth Muscle Actin, Clone 1A4, Ready-to-Use (Link) Monoclonal Mouse Anti-Human Wilms' Tumor 1 (WT1) Protein, Clone 6F-H2 FLEX Polyclonal Rabbit Anti-Human Carcinoembryonic Antigen Monoclonal Mouse Anti-Human CD44, Phagocytic Glycoprotein-1, Clone DF1485 Monoclonal Mouse Anti-Human MUM1 Protein, Clone MUM1p FLEX Monoclonal Mouse Anti-Human Neurofilament Protein, Clone 2F11, Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Human Gross Cystic Disease Fluid Protein-15, Clone 23A3, RTU (Dako Autostainer) Polyclonal Rabbit Anti-Human IgE FLEX Monoclonal Mouse Anti-Human Amyloid A, Clone mc1, Ready-to-Use (Dako Autostainer/Autostainer Plus) FLEX Monoclonal Mouse Anti-Human Epithelial Antigen, Clone Ber-EP4, Ready-to-Use (Dako Omnis) FLEX Polyclonal Rabbit Anti-Human Calcitonin, Ready-to-Use (Dako Autostainer/Autostainer Plus) Monoclonal Mouse Anti-Human MAGE-C1, Clone CT7-33 FLEX Monoclonal Mouse Anti-Human Gross Cystic Disease Fluid Protein-15, Clone 23A3, Ready-to-Use (Link) Monoclonal Mouse Anti-Human CD43, Clone DF-T1 FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Monoclonal Mouse Anti-Human N-Cadherin, Clone 6G11 FLEX Monoclonal Mouse Anti-Human MUM1 Protein, Clone MUM1p, Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Human Nucleophosmin, Clone 376, Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Human Mammaglobin, Clone 304-1A5 Ready-to-use (Dako Autostainer/Autostainer Plus) FLEX Monoclonal Mouse Anti-Human MUM1 Protein, Clone MUM1p, Ready-to-Use (Dako Omnis) Polyclonal Rabbit Anti-Human CD3 Monoclonal Mouse Anti-Human BCL6 Protein, Clone PG-B6p Monoclonal Mouse Anti-Human Plasma Cell, Clone VS38c Monoclonal Rabbit Anti-Human Terminal Deoxynucleotidyl Transferase, Clone EP266 FLEX Monoclonal Mouse Anti-Human CD45, Leucocyte Common Antigen, Clones 2B11 + PD7/26, Ready-to-Use (Dako Omnis) FLEX Polyclonal Rabbit Anti-Glial Fibrillary Acidic Protein, Ready-to-Use (Link) Monoclonal Mouse Anti-Human Podoplanin, Clone D2-40 FLEX Polyclonal Rabbit Anti-Human Gastrin, Ready-to-Use (Link) Monoclonal Mouse Anti-Human p27Kip1, Clone SX53G8 Monoclonal Mouse Anti-Human CD105, Endoglin, Clone SN6h FLEX Monoclonal Rabbit Anti-Human AMACR, Clone 13H4, Ready-to-Use (Dako Autostainer/Autostainer Plus) FLEX Polyclonal Rabbit Anti-Glial Fibrillary Acidic Protein, Ready-to-Use (Dako Omnis) FLEX Monoclonal Anti-Human MSH2 FE11, Ready-to-use (Link) FLEX Polyclonal Rabbit Anti-Glial Fibrillary Acidic Protein, Ready-to-Use (Dako Autostainer/Autostainer Plus) Monoclonal Mouse Anti-Human Prostein, Clone 10E3 FLEX Polyclonal Rabbit Anti-Human Alpha-1-Fetoprotein, Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Human Octamer-binding Transctrption Factor 3/4 (Oct3/4), Clone N1NK, Ready-to-use (Link) FLEX Monoclonal Mouse Anti-Human p63 Protein, Clone DAK-p63, Ready-To-Use (Dako Omnis) Monoclonal Mouse Anti-Metallothionein, Clone E9 FLEX Monoclonal Mouse Anti-Human CD23, Clone DAK-CD23, Ready-to-Use (Dako Autostainer/Autostainer Plus) FLEX Polyclonal Rabbit Anti-Human Prostate Specific Antigen, Ready-to-Use (Link) Monoclonal Mouse Anti-Human Tyrosinase, Clone T311 Monoclonal Mouse Anti-Human Epithelial Membrane Antigen, Clone E29 Polyclonal Rabbit Anti-Human Tau Monoclonal Mouse Anti-Human Cytokeratin 7, Clone OV-TL 12/30 FLEX Monoclonal Mouse Anti-Human CD68, Clone KP1, Ready-to-Use (Link) Monoclonal Mouse Anti-Human MITF, Clone D5 DuoFLEX Cocktail Anti-CD3 Anti-CD20cy, Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Human CD45, Leucocyte Common Antigen, Clones 2B11 + PD7/26, Ready-to-Use (Link) Polyclonal Rabbit Anti-Human Von Willebrand Factor Monoclonal Mouse Anti-Human CD99, MIC2 Gene Products, Ewing's Sarcoma Marker, Clone 12E7 Monoclonal Mouse Anti-Human CD31, Endothelial Cell, Clone JC70A FLEX Monoclonal Mouse Anti-Human CD30, Clone Ber-H2, Ready-to-Use (Dako Autostainer/Autostainer Plus) Monoclonal Mouse Anti-Human ERCC1, Clone 4F9 FLEX Monoclonal Mouse Anti-Human CD57, Clone TB01, Ready-to-Use (Link) Monoclonal Mouse Anti-Human Caldesmon, Clone h-CD Polyclonal Rabbit Anti-Glial Fibrillary Acidic Protein FLEX Monoclonal Rabbit Anti-Human Cyclin D1, Clone EP12, Ready-to-Use (Dako Autostainer/Autostainer Plus) FLEX Monoclonal Mouse Anti-Human Beta-Catenin, Clone beta-Catenin-1, Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Human CD68, Clone PG-M1, Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Human Calretinin, Clone DAK-Calret 1, Ready-to-Use (Link) FLEX Monoclonal Rabbit Anti-Human AMACR, Clone 13H4 Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Human Amyloid A, Clone mc1, Ready-to-Use (Dako Omnis) DuoFLEX Cocktail Anti-S100 Anti-Tyrosinase Anti-Melan-A Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Human Carcinoembryonic Antigen, Clone II-7, Ready-to-Use (Dako Omnis) FLEX Polyclonal Rabbit Anti-Human IgA, Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Human CD1a, Clone 010, Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Human CD10, Clone 56C6, Ready-to-Use (Dako Autostainer/Autostainer Plus) Monoclonal Mouse Anti-Human Epithelial-Related Antigen, Clone MOC-31 FLEX Monoclonal Rabbit Anti-Human P504S, Clone 13H4, Ready-to-Use (Dako Autostainer/Autostainer Plus) Monoclonal Mouse Anti-Human Androgen Receptor, Clone AR441 Monoclonal Mouse Anti-Human Cytokeratin 18, Clone DC 10 FLEX Polyclonal Rabbit Anti-S100, Ready-to-Use (Dako Omnis) FLEX Polyclonal Rabbit Anti-Human Lambda Light Chains, Ready-to-Use (Dako Omnis) Polyclonal Rabbit Anti-Human Alpha-1-Fetoprotein FLEX Monoclonal Mouse Anti-Human Synaptophysin, Clone DAK-SYNAP, Ready-to-Use (Dako Omnis) Monoclonal Mouse Anti-Human Collagen IV, Clone CIV 22 FLEX Polyclonal Rabbit Anti-Human IgA, Ready-to-Use (Dako Autostainer/Autostainer Plus) FLEX Monoclonal Mouse Anti-Human CD10, Clone 56C6, Ready-to-Use (Dako Omnis) Monoclonal Mouse Anti-Human Prostate-Specific Membrane Antigen, Clone 3E6 FLEX Monoclonal Mouse Anti-Human Melanosome, Clone HMB45, Ready-to-Use (Dako Omnis) FLEX Monoclonal Mouse Anti-Human Inhibin , Clone R1, Ready-to-Use (Dako Omnis) FLEX Monoclonal Mouse Anti-Human Cytokeratin 19, Clone RCK108, Ready-to-Use (Dako Autostainer/Autostainer Plus) FLEX Monoclonal Mouse Anti-Human CD34 Class II, Clone QBEnd 10, Ready-to-Use (Dako Omnis) Monoclonal Mouse Anti-Human HLA-DP, DQ, DR Antigen, Clone CR3/43 FLEX Monoclonal Mouse Anti-Human CD138, Clone MI15, Ready-to-Use (Dako Omnis) Monoclonal Mouse Anti-Human CD79alphacy, Clone HM57 Monoclonal Mouse Anti-Human Serotonin, Clone 5HT-H209 FLEX Monoclonal Mouse Anti-Human B-cell Specific Activator Protein, Clone DAK-PAX5, RTU (Dako Autostainer) FLEX Monoclonal Mouse Anti-Human CD19, Clone LE-CD19, Ready-to-Use (Dako Omnis) FLEX Universal Negative Control, Mouse, Ready-to-Use (Link) Monoclonal Mouse Anti-Human Smooth Muscle Myosin Heavy Chain, Clone SMMS-1 FLEX Monoclonal Mouse Anti-Human Neuron-Specific Enolase, Clone BBS/NC/VI-H14, RTU (Dako Autostainer/Autostainer Plus) FLEX Monoclonal Mouse Anti-Human CD43, Clone DF-T1, Ready-to-Use (Link) Monoclonal Mouse Anti-Human CD4, Clone 4B12 FLEX Monoclonal Mouse Anti-Human CDX2, Clone DAK-CDX2, Ready-to-Use (Dako Omnis) Monoclonal Mouse Anti-Human CD138, Clone MI15 FLEX Monoclonal Mouse Anti-Human Podoplanin, Clone D2-40, Ready-to-Use (Dako Autostainer/Autostainer Plus) Monoclonal Mouse Anti-Human CD8, Clone C8/144B FLEX Monoclonal Mouse Anti-Human CD43, Clone DF-T1, Ready-to-Use (Dako Autostainer/Autostainer Plus) Monoclonal Mouse Anti-Human CD15, Clone Carb-3 Monoclonal Mouse Anti-Human Cytokeratin 10/13, Clone DE-K13 Monoclonal Mouse Anti-Human Glycophorin C, Clone Ret40f Polyclonal Rabbit Anti-Human Glucagon FLEX Monoclonal Mouse Anti-Human CD68, Clone KP1, Ready-to-Use (Dako Omnis) FLEX Monoclonal Mouse Anti-Human B-Cell-Specific Activator Protein, Clone DAK-Pax5, Ready-to-Use (Dako Omnis) FLEX Polyclonal Rabbit Anti-Human CD3, Ready-to-Use (Dako Omnis) FLEX Monoclonal Mouse Anti-Human CDX2, Clone DAK-CDX2, Ready-to-Use (Dako Autostainer/Autostainer Plus) FLEX Universal Negative Control, Rabbit, Ready-to-Use (Dako Omnis) FLEX Monoclonal Mouse Anti-Human ZAP-70, Clone 2F3.2, Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Human Smooth Muscle Myosin Heavy Chain, Clone SMMS-1 Ready-to-Use (Link) DuoFLEX Cocktail Anti-AMACR Anti-CKHMW Anti-CK5/6, Ready-to-Use (Dako Autostainer/Autostainer Plus) FLEX Polyclonal Rabbit Anti-Human IgM, Ready-to-Use (Dako Omnis) FLEX Monoclonal Mouse Anti-Synaptophysin, Clone SY38, Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Thyroid Transcription Factor, Clone 8G7G3/1, RTU (Dako Autostainer/Autostainer Plus) FLEX Monoclonal Mouse Anti-Human p53 Protein, Clone DO-7, Ready-to-Use (Dako Omnis) FLEX Polyclonal Rabbit Anti-Human IgG, Ready-to-Use (Link) Monoclonal Mouse Anti-Human CA 125, Clone M11 Monoclonal Mouse Anti-Human CD68, Clone KP1 FLEX Polyclonal Rabbit Anti-Human Calcitonin, Ready-to-Use (Dako Omnis) DuoFLEX Cocktail Anti-AMACR Anti-CKHMW Anti-CK5/6, Ready-to-Use (Link) Monoclonal Mouse Anti-Human CD45R0, Clone UCHL1 FLEX Monoclonal Mouse Anti-Human p53 Protein, Clone DO-7, Ready-to-Use (Link) Polyclonal Rabbit Anti-Cytokeratin, Wide Spectrum Screening FLEX Monoclonal Mouse Anti-Human Prostein, Clone 10E3, Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Human CD1a, Clone 010, Ready-to-Use (Dako Autostainer/Autostainer Plus) FLEX Monoclonal Mouse Anti-Human Carcinoembryonic Antigen, Clone II-7, Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Human Renal Cell Carcinoma Marker, Clone SPM314 Ready-to-Use (Link) FLEX Polyclonal Rabbit Anti-Human IgD, Ready-to-Use (Dako Autostainer/Autostainer Plus) FLEX Polyclonal Guinea Pig Anti-Insulin, Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Human CD8, Clone C8/144B, Ready-to-Use (Dako Omnis) Monoclonal Mouse Anti-human LAT Protein, Clone LAT-1 FLEX Polyclonal Rabbit Anti-Human Kappa Light Chains, Ready-to-Use (Dako Omnis) FLEX Monoclonal Mouse Anti-Human Podoplanin, Clone D2-40 Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Myogenin, Clone F5D, Ready-to-Use (Dako Autostainer/Autostainer Plus) FLEX Monoclonal Mouse Anti-Human Cytokeratin, High Molecular Weight, Clone 34BE12, Ready-to-Use (Link) FLEX Monoclonal Rabbit Anti-Human ERG, Clone EP111, Ready-to-Use (Dako Omnis) FLEX Monoclonal Mouse Anti-Human CD68, Clone PG-M1, Ready-to-Use (Dako Omnis) FLEX Monoclonal Mouse Anti-Human Tyrosinase, Clone T311, Ready-to-Use (Link) FLEX Monoclonal Rabbit Anti-Human Cyclin D1, Clone EP12, Ready-to-Use (Dako Omnis) Monoclonal Mouse Anti-Human Epidermal Growth Factor Receptor, Clone E30 Monoclonal Rabbit Anti-Human Cyclin D1, Clone EP12 Monoclonal Mouse Anti-Human Epidermal Growth Factor Receptor, Clone H11 FLEX Polyclonal Rabbit Anti-Human Von Willebrand Factor, Ready-to-Use (Dako Autostainer/Autostainer Plus) FLEX Monoclonal Mouse Anti-Human Epithelial Membrane Antigen, Clone E29, Ready-to-Use (Dako Autostainer/Autostainer Plus FLEX Polyclonal Rabbit Anti-Human Thyroglobulin, Ready-to-Use (Link) Monoclonal Mouse Anti-Myogenin, Clone F5D FLEX Monoclonal Mouse Anti-Human CD30, Clone Ber-H2, Ready-to-Use (Dako Omnis) FLEX Monoclonal Mouse Anti-Human MutS Protein Homolog 2, Clone FE11, Ready-to-Use (Link) Monoclonal Mouse Anti-Human Cytokeratin, Clone AE1/AE3 FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Human CD2, Clone AB75, Ready-to-Use (Link) Monoclonal Mouse Anti-Human Cytokeratin, High Molecular Weight, Clone 34BE12 FLEX Monoclonal Mouse Anti-Human Placental Alkaline Phosphatase, Clone 8A9, Ready-to-Use (Link) Polyclonal Guinea Pig Anti-Insulin FLEX Monoclonal Mouse Anti-Human Mammaglobin, Clone 304-1A5, Ready-to-Use (Dako Omnis) Monoclonal Mouse Anti-Human Neurofilament Protein, Clone 2F11 Monoclonal Mouse Anti-Human CD61, Platelet Glycoprotein IIIa, Clone Y2/51 FLEX Monoclonal Mouse Anti-Human Cytokeratin 18, Clone DC 10, Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Human Smooth Muscle Myosin Heavy Chain, Clone SMMS-1, Ready-to- Use (Dako Autostainer) FLEX Monoclonal Mouse Anti-Human CD8, Clone C8/144B, Ready-to-Use (Dako Autostainer/Autostainer Plus) FLEX Monoclonal Mouse Anti-Human CD79alpha, Clone JCB117, Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Human Cytokeratin, Clone AE1/AE3, Ready-to-Use (Dako Autostainer/Autostainer Plus) Monoclonal Mouse Anti-Human Follicle-Stimulating Hormone (FSH), Clone C10 FLEX Polyclonal Rabbit Anti-Human Myeloperoxidase, Ready-to-Use (Dako Autostainer/Autostainer Plus) Monoclonal Mouse Anti-Human CD1a, Clone O10 Monoclonal Mouse Anti-Human Renal Cell Carcinoma Marker, Clone SPM314 Monoclonal Mouse Anti-Human Synaptophysin, Clone DAK-SYNAP Monoclonal Mouse Anti-Human Cytokeratin 10, Clone DE-K10 FLEX Monoclonal Mouse Anti-Human Renal Cell Carcinoma Marker, Clone SPM314, Ready-to-Use (Dako Omnis) Monoclonal Mouse Anti-Human Calponin, Clone CALP FLEX Monoclonal Mouse Anti-Human B-cell Specific Activator Protein, Clone DAK-PAX5, Ready-to-Use (Link) Monoclonal Mouse Anti-Human Inhibin , Clone R1 Monoclonal Mouse Anti-Human MUC5AC, Clone CLH2 Monoclonal Mouse Anti-Human p53 Protein, Clone DO-7 Monoclonal Mouse Anti-Human CD21, Clone 1F8 FLEX Monoclonal Mouse Anti-Human MUC5AC, Clone CLH2, Ready-to-Use (Link) Monoclonal Mouse Anti-Human CD23, Clone DAK-CD23 FLEX Monoclonal Mouse Anti-Human Epithelial Membrane Antigen, Clone E29, Ready-to-Use (Dako Omnis) Monoclonal Mouse Anti-Cytokeratin 17, Clone E3 FLEX Monoclonal Mouse Anti-Human Inhibin , Clone R1, Ready-to-Use (Dako Autostainer/Autostainer Plus) Monoclonal Mouse Anti-Human Beta-Catenin, Clone Beta-Catenin-1 DuoFLEX Cocktail Anti-S100 Anti-Tyrosinase Anti-Melan-A, Ready-to-Use (Dako Autostainer/Autostainer Plus) FLEX Monoclonal Mouse Anti-Human CD99, MIC2 Gene Product Ewing's Sarcoma Marker, Clone 12E7 (Link) Polyclonal Swine Anti-Rabbit Immunoglobulins Monoclonal Mouse Anti-Synaptophysin, Clone SY38 FLEX Monoclonal Mouse Anti-Human Cytokeratin 20, Clone Ks20.8, Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Human CD15, Clone Carb-3, Ready-to-Use (Dako Autostainer/Autostainer Plus) FLEX Polyclonal Rabbit Anti-Human Thyroglobulin, Ready-to-Use (Dako Autostainer/Autostainer Plus) FLEX Monoclonal Mouse Anti-Human BCL2 Oncoprotein, Clone 124, Ready-to-Use (Link) Monoclonal Mouse Anti-Human CD56, Clone 123C3 Polyclonal Rabbit Anti-Human Chorionic Gonadotropin FLEX Polyclonal Rabbit Anti-Human Thyroglobulin, Ready-to-Use (Dako Omnis) Monoclonal Mouse Anti-Human CD45, Leucocyte Common Antigen, Clones 2B11 + PD7/26 Polyclonal Rabbit Anti-PGP 9.5 Negative Control, Rabbit Immunoglobulin Fraction (Solid-Phase Absorbed) Monoclonal Mouse Anti-Human MutS Protein Homolog 2, Clone FE11 Monoclonal Mouse Anti-Human Mesothelial Cell, Clone HBME-1 Monoclonal Mouse Anti-Human Carcinoembryonic Antigen, Clone II-7, Ready-to-Use FLEX Monoclonal Mouse Anti-Human Epithelial Antigen, Clone Ber-EP4, Ready-to-Use (Link) FLEX Universal Negative Control, Rabbit, Ready-to-Use (Link) FLEX Polyclonal Rabbit Anti-Human Lambda Light Chains, Ready-to-Use (Link) FLEX Polyclonal Rabbit Anti-Human Gastrin, Ready-to-Use (Dako Omnis) FLEX Monoclonal Mouse Anti-Human CD23, Clone DAK-CD23, Ready-to-Use (Dako Omnis) Monoclonal Mouse Anti-Human Cytokeratin 19, Clone RCK108 Monoclonal Mouse Anti-Human Nucleophosmin, Clone 376 FLEX Negative Control, Mouse, Cocktail of mouse IgG1, IgG2a, IgG2b, IgG3 and IgM, Ready-to-Use (Link) FLEX Monoclonal Mouse Anti-Human CD10, Clone DAK-CD10, Ready-to-Use (Dako Omnis) FLEX Monoclonal Mouse Anti-Human CD246-ALK Protein, Clone OTI1A4, Ready-to-Use (Dako Omnis) FLEX Monoclonal Mouse Anti-Human CD10, Clone DAK-CD10, Ready-to-Use (Link) FLEX Monoclonal Rabbit Anti-Human p40, Clone DAK-p40, Ready-to-Use (Dako Omnis) FLEX Monoclonal Mouse Anti-Human MSH2, Clone FE11, Ready-to-Use (Dako Omnis) FLEX Monoclonal Mouse Anti-Human MLH1, Clone ES05, Ready-to-Use (Dako Omnis) FLEX Monoclonal Rabbit Anti-Human PMS2, Clone EP51, Ready-to-Use (Dako Omnis) FLEX Monoclonal Rabbit Anti-Human MSH6, Clone EP49, Ready-to-Use (Dako Omnis) FLEX Monoclonal Mouse Anti-Human p16, Clone JC8, Ready-to-Use (Dako Omnis) Monoclonal Mouse Anti-Human CD79alpha, Clone JCB117 Monoclonal Mouse Anti-Human CD68, Clone PG-M1 FLEX Monoclonal Mouse Anti-Human Melan-A, Clone A103, Ready-to-Use (Dako Omnis) Beckman Coulter Beta-2-Microglobulin Kit Polyclonal Rabbit Anti-Human Kappa Light Chains/FITC Polyclonal Rabbit Anti-Human C3c Complement/FITC Dako Toulene-Free Mounting Medium DAKO MOUNTING MEDIUM Artisan Recticulin/No Counterstain Stain Kit Artisan Alcian Blue/PAS/Hematoxylin Stain Kit Artisan Alcian Blue/PAS Stain Kit Artisan Alcian Blue pH 2.5 Stain Kit Artisan Alcian Yellow Toludine Blue HercepTest for Automated Link Platforms K1201A GenetiSure Dx Postnatal Assay K1201-64200 GenetiSure Dx Hybridization Kit K1201-64100 GenetiSure Dx DNA Labeling Kit K1201-64400 GenetiSure Dx Cot-1 Human DNA K1201-64300 GenetiSure Dx Wash Buffer Set Dako Modified Eosin Y Dako Eosin Y Phloxine B DAKO EOSIN Polyclonal Rabbit Anti-S100 Dako PT Link Pascal Hybridizer PT Link Dako PT Link (PT200) Pascal Quality Strips Hybridizer Humidity Control Strips Polyclonal Rabbit Anti-Human C4c Complement/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) Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294 Artisan Gomori's Green Trichrome Stain Kit Artisan Grocott's Methenamine Silver Eosin Stain Kit Artisan Grocott's Methenamine Silver (GMS) Stain Kit Ki-67 IHC MIB-1 pharmDx (Dako Omnis) FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor ?, Clone EP1, Ready-to-Use (Link) DAKO COVER GLASS 24 x 50 mm Hematoxylin, Mayer's Artisan Mayer's Hematoxylin Polyclonal Rabbit Anti-Human Lambda Light Chains Uti-Lyse, Erythrocyte-Lysing Reagent EasyLyse, Erythrocyte-Lysing Reagent IntraStain K6460 Triple Quadrupole MS – AJS K6420 Triple Quadrupole MS K6490 Triple Quadrupole MS K6460 Triple Quadrupole MS – ESI Artisan Gomori's Trichrome Stain Kit Dako Differentation Solution Dako Bluing Buffer MultiMix Dual-Colour Reagent, Anti-Human CD45/FITC + Anti-Human CD14/RPE Isotype Reagent, Mouse IgG1/PerCP Telomere PNA Kit/FITC for Flow Cytometry MultiMix Triple-Colour Reagent, Anti-Human CD41/FITC, Anti-Human CD34/RPE, Anti-Human CD61/APC Monoclonal Mouse Anti-Human CD27/FITC, Clone M-T271 Polyclonal Rabbit Anti-Human S100A4 Monoclonal Mouse Anti-Human EGFR-pY1197, Phosphorylation Site Specific, Clone DAK-H1-1197 Dako EyeShare Software - 5 License Pack Rabbit Serum (Normal) Monoclonal Mouse Anti-Human Ribosomal Protein S6-pS240, Phosphorylation Site Specific, Clone DAK-S6-240 ARK (Animal Research Kit)/HRP Polyclonal Rabbit Anti-Human IgM/FITC, Rabbit F(ab')2 Negative Control, Rabbit Immunoglobulin Fraction (Normal) Epstein-Barr Virus (EBER) PNA Probe/Fluorescein Monoclonal Mouse Anti-Human CD54, ICAM-1/FITC, Clone 6.5B5 Monoclonal Mouse Anti-Human HLA-DR Antigen, Alpha-Chain, Clone TAL.1B5 Dako LSAB2 System-HRP for use on Rat Specimens Monoclonal Mouse Anti-Human CD28/RPE, Clone CD28.1 FluoroSpheres Monoclonal Mouse Anti-Human CD27/RPE, Clone M-T271 Goat Serum (Normal) Monoclonal Mouse Anti-Human CD86/FITC, Clone BU63 ACIS III Tissue Micro-Array Application Software Monoclonal Mouse Anti-Bromodeoxyuridine, Clone Bu20a Isotype Reagent, Mouse IgG1/PB MultiMix Triple-Colour Reagent, Anti-Human CD2/FITC + Anti-Human CD34 Class III/RPE + Anti-Human CD5/APC Monoclonal Mouse Anti-Human Fascin, Clone 55K-2 QIFIKIT Polyclonal Rabbit Anti-FITC/HRP, Rabbit F(ab')* Swine Serum (Normal) Monoclonal Mouse Anti-Human Wild-Type EGFR, Clone DAK-H1-WT Dako EyeShare Software - 25 License Pack MultiMix Triple-Colour Reagent, Anti-Human CD33/FITC, Anti-Human CD34/RPE, Anti-Human CD117/APC Polyclonal Rabbit Anti-Cow Immunoglobulins/HRP Monoclonal Mouse Anti-Rabbit Macrophage, Clone RAM11 Monoclonal Mouse Anti-Rat Ki-67 Antigen, Clone MIB-5 Monoclonal Mouse Anti-Human CD69/RPE, Clone FN50 Polyclonal Rabbit Anti-Human C1q Complement/FITC MultiMix Triple-Colour Reagent, Anti-Human CD19/FITC, Anti-Human CD34/RPE, Anti-Human CD22/APC Telomere PNA FISH Kit/FITC New Fuchsin Substrate System FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis) PD-L1 IHC 28-8 pharmDx G5761A SureScan Dx MicroArray Scanner HER2 IQFISH pharmDx Polyclonal Rabbit Anti-Human IgM Polyclonal Rabbit Anti-Human Lambda Light Chains/FITC T1391 PD-L1 Control Slides Artisan Reticulin/Nuclear Fast Red Stain Kit FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use (Link)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HZC Mucicarmine Hematology Class 1 864.1850 2020-09-23
LIJ Peroxidase Anti-Peroxidase Immunohistochemical Stain Pathology Class 1 864.4400 2020-09-23
KEM Agent, Clearing Pathology Class 1 864.4010 2020-09-24
JZJ Prealbumin, Antigen, Antiserum, Control Immunology Class 1 866.5060 2020-09-24
DGK Igg, Fitc, Antigen, Antiserum, Control Immunology Class 2 866.5510 2020-09-25
CZS Retinol-Binding Protein, Antigen, Antiserum, Control Immunology Class 1 866.5765 2020-11-03
DGR Whole Human Serum, Antigen, Antiserum, Control Immunology Class 1 866.5700 2020-09-24
GKZ Counter, Differential Cell Hematology Class 2 864.5220 2020-10-06
HYF Giemsa Stain Hematology Class 1 864.1850 2020-09-23
GKZ Counter, Differential Cell Hematology Class 2 864.5220 2020-10-06
GKZ Counter, Differential Cell Hematology Class 2 864.5220 2020-10-06
HZD Muller'S Colloidal Iron Hematology Class 1 864.1850 2020-09-23
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
HZA Methyl Green Hematology Class 1 864.1850 2020-09-23
GGH Iron Stains Hematology Class 1 864.1850 2020-09-23
DFH Kappa, Antigen, Antiserum, Control Immunology Class 2 866.5550 2020-09-25
OUG Medical Device Data System General Hospital Class 1 880.6310 2020-09-24
DFS Igm, Fitc, Antigen, Antiserum, Control Immunology Class 2 866.5550 2020-09-25
ICF Crystal Violet For Histology Hematology Class 1 864.1850 2020-09-23
NJT Immunohistochemistry Reagents And Kits Hematology Class 1 864.1860 2020-09-23
JZG System, Test, Beta-2-Microglobulin Immunological Immunology Class 2 866.5630 2020-09-25
DEO Kappa, Fitc, 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
LEB Mounting Media Pathology Class 1 864.4010 2020-09-24
ICZ Ammoniacal Silver Hydroxide Silver Nitrate Hematology Class 1 864.1850 2020-09-23
IDA Alcian Blue Hematology Class 1 864.1850 2020-09-23
MVC System, Test, Her-2/Neu, Ihc Unknown Class 3 N/A 2020-10-06
PFX System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection Immunology Class 2 866.5920 2017-10-23
HYB Eosin Y Hematology Class 1 864.1850 2020-09-24
DEH Lambda, Antigen, Antiserum, Control Immunology Class 2 866.5550 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
DBI Complement C4, Antigen, Antiserum, Control Immunology Class 2 866.5240 2020-09-25
PPM General Purpose Reagent Pathology Class 1 864.4010 2014-11-25
MXZ Immunohistochemistry Assay, Antibody, Progesterone Receptor Hematology Class 2 864.1860 2020-09-25
MYA Immunohistochemistry Antibody Assay, Estrogen Receptor Hematology Class 2 864.1860 2020-09-25
HYS Light Green Hematology Class 1 864.1850 2020-09-23
HYZ Methenamine Silver Hematology Class 1 864.1850 2020-09-23
QQT Immunohistochemistry Assay, Antibody, Ki-67 Unknown Class 3 N/A 2021-10-18
MYA Immunohistochemistry Antibody Assay, Estrogen Receptor Hematology Class 2 864.1860 2020-09-25
KES Coverslips, Microscope Slide Pathology Class 1 864.3010 2020-09-24
HYL Hematoxylin Mayer'S Hematology Class 1 864.1850 2020-09-23
DEH Lambda, Antigen, Antiserum, Control Immunology Class 2 866.5550 2020-09-25
GGK Products, Red-Cell Lysing Products Hematology Class 1 864.8540 2020-09-23
DOP Mass Spectrometer, Clinical Use Clinical Chemistry Class 1 862.2860 2011-11-22
KFD Aniline Blue Hematology Class 1 864.1850 2020-09-23
LEE Stains, Dye Solution Hematology Class 1 864.1850 2020-09-23
GKZ Counter, Differential Cell Hematology Class 2 864.5220 2020-10-06
OTU Research Use Only/Pathology Unknown Class N N/A 2021-01-07
MXZ Immunohistochemistry Assay, Antibody, Progesterone Receptor Hematology Class 2 864.1860 2020-09-25
PLS Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1 Unknown Class 3 N/A 2020-10-06
NSU Instrumentation For Clinical Multiplex Test Systems Clinical Chemistry Class 2 862.2570 2017-10-17
MVD System, Test, Her-2/Neu, Nucleic Acid Or Serum Unknown Class 3 N/A 2020-12-16
DAO Igm (Mu Chain Specific), Antigen, Antiserum, Control Immunology Class 2 866.5550 2020-09-25
DES Lambda, Fitc, Antigen, Antiserum, Control Immunology Class 2 866.5550 2020-09-25
KIR Cells, Animal And Human, Cultured Hematology Class 1 864.2280 2021-04-20
HZF Nuclear Fast Red Hematology Class 1 864.1850 2020-09-23
MXZ Immunohistochemistry Assay, Antibody, Progesterone Receptor Hematology Class 2 864.1860 2020-09-25

Official Correspondent

Widad Ghaben

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Agilent Technologies, Inc
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K910283 Danam Electronics DANAM DATACELL-18 1991-04-12
K102064 Becton, Dickinson & CO BD FACS SAMPLE PREP ASSISTANT III (SPA III) 2011-03-07
K822676 Amico Lab, Inc. FITC ANTISERA TO HUMAN IGG 1982-11-17

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

Registration Number Establishment Name Location
1937990 SIGMA-ALDRICH MANUFACTURING, LLC-H&H Saint Louis, MO, US
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2022180 Agilent Technologies, Inc. CARPINTERIA, CA, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009189893. Last updated year: 2026. Please use registration number 3009189893 when referencing this establishment in official correspondence.
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