Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004859032

FEI Number

3004859032

Entity Name

LEICA BIOSYSTEMS NEWCASTLE LTD

City/State/Country

NEWCASTLE UPON TYNE, GB

Establishment Address

BALLIOL BUSINESS PARK WEST, BENTON LANE, NEWCASTLE UPON TYNE NE12 8EW, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Leica Biosystems, division of Leica Microsystems, Inc. (Owner Number: 10054155)

Owner / Operator Contact Address

21440 W. Lake Cook Road, Floor 5, Deer Park, IL 60010, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K213348

PMA Number

N/A

All Registered Proprietary Names

Epitope Retrieval Solution pH6 (x10 conc) Primary Antibody Diluent 0.5L (BOND) DEFINE MX-AQ (4-500ML BTL) Solution B for coating slides 250 mL bo Peroxidase Block Bond Enzyme Pretreatment Kit (BOND) Haematoxylin METHENAMINE/BORAX SOLUTIONJ 250 ML Solution A Slide Pre-Treatment Solution BOND RNAscope Detection Reagents-BROWN HYDROCHLORIC ACID SOLUTION 500ML ACID ALCOHOL 1% (4 GALS) ISOPROPYL ALCOHOL (4 GALS) SelecTech Blue Buffer 8 Concentrate REAGENT ALCOHOL 100% (4 GALS) Scotts Tap Water, Concentrate, Pint 1 Case of 4 pieces Stringency Wash Solution (BOND ready-to-use) Epitope Retrieval Solution pH9 (x10 conc) DEFINE (4-500ML BTL) Waxsol Cleaning Solution Wash Solution 10X - 1L (BOND) Anti-Biotin Stringency Wash DAB Enhancer 30ml (BOND ready-to-use) BOND RNAscope Protease Define MX-aq Ready-to-use Epitope Retrieval 2-1L (BOND) IHC Diluent XYLENE (4 GALS) Anti-Fluorescein Ab (BOND ready-to-use) Protein Block Epitope Retrieval Solution pH8 (x10 conc) 1% ACETIC ACID 500ML Epitope Retrieval 1-1L (BOND) Anti-Biotin Antibody (BOND ready-to-use) Proteinase K Kit BOND FISH Kit SelecTech Blue Buffer 8 Ready-to-Use Scotts tap Water, Working Solution, Gallon (3.8L) 1 Gallon BORAX SOLUTION DEFINE MX-AQ (500ML) POTASSIUM HYDROXIDE SOLUTION 100ML ACID ALCOHOL 1% (GAL) 4 SLIDE JARS 250/BULK BAG Aqueous Buffer Salt Mix REAGENT ALCOHOL 95% (4 GALS) DEFINE (500ML) Bond Dewax Solution (BOND) REAGENT ALCOHOL 80% (4 GALS) REAGENT ALCOHOL 70% (4 GALS) BOND-PRIME Wash Solution Concentrate BOND-PRIME Epitope Retrieval Solution 1 BOND-PRIME Epitope Retrieval Solution 2 BOND-PRIME Haematoxylin BOND-PRIME Dewax Solution BOND-PRIME Covertile Cleaning Kit DAPI/Antifade 1 ?g/ml (DAPI Counterstain) Pepsin Solution BOND-PRIME RNAscope® Brown Detection System LKU-141C Tissue Digestion Kit II LKU-141B DAPI/Antifade 0,1 ?g/ml (DAPI Counterstain) 2x SSC solution 0.4x SSC / 0.3% Igepal (Wash Buffer I) FISH Reagent Kit DAPI Counterstain (1 ?g/ml) LKU-110C Tissue Digestion Kit I 2x SSC / 0.1% Igepal (Wash Buffer II) FISH Digestion Kit LKU-061A Antifade (Counterstain diluent) POSEIDON FISH Hybridization Buffer (FHB) 2x SSC solution / 0.5% Igepal LKU-100C 0.2 M Hydrochloric acid Counterstain Diluent DAPI Counterstain (0.1 ?g/ml) 08C001B495 14Q001C495 03Q002B495 20P001I495 05Q002B550 04P001B495 23C004J495 03Q004C550 FOXO1 (13q14) Distal - XL 09P003B495 08Q005B495 CCND1 (11q13) Proximal - XL 14Q001C415 03Q008B495 18C004J415 02P001B495 20P001B495 08Q002I550 12C001J495 05Q004I550 06Q007V550 10Q002B550 09P004B550 07Q002V550 24C003J550 KI-20006R 09Q004C415 03Q004B550 NTRK1 (1q23) Distal - XL 40V031V495 08C003V495 14Q001I550 17C007V495 23P001B550 24C002N415 06Q005B550 18Q001B495 18C001J415 KI-20011G 03Q005C495 21Q002B550 20Q003I550 18Q002B550 01Q001I550 13Q002I495 FUS (16p11) Distal - XL 21Q001I495 CCND1 (11q13) Distal - XL 03Q009V495 08P002B550 23P004C550 13Q001C550 06Q003B550 KI-20008R 08Q001I550 03Q001B550 05Q001B495 SS18 (18q11) Proximal - XL 07C003J415 09P005B550 09C001C550 18Q003V495 FUS (16p11) Proximal - XL 24C004J550 KI-20001G 07C002I495 23C002J495 17Q001I495 NTRK1 (1q23) Proximal - XL 23P003C495 04Q005B550 ACD RNA ISH Probe CMV Aurora Kinase 2 ACD RNA ISH Probe Napsin A Vascular endothelial Growth Factor Receptor 3 Pax-5 7mL NCL RTU EBER Probe-ASR 7mL NCL RTU Lambda Probe-ASR Helicobacter pylori (liquid primary antibody) ACD RNA ISH Probe 7mL NCL RTU RNAPosContProbe-ASR ACD RNA ISH Probe HPV-31 (RS7759) Cytokeratin 8 ACD RNA ISH Probe TTF1 (Thyroid Transcription Factor-1) 7mL NCL RTU RNANegContProbe-ASR B Cell Specific Octamer Bind Protein-1 (BOB-1) 7mL NCL RTU CMV Probe-ASR ACD RNA ISH Probe (concentrate) HPV-33 (RS7863) 7mL NCL RTU Kappa Probe-ASR ACD RNA ISH Probe DapB (Negative Control) ACD RNA ISH Probe UBC (Pos. Ctrl.) ACD RNA ISH Probe HPV-16 (RS7758) ACD RNA ISH Probe HPV-6 (RS7757) CD25 (Interleukin 2 Receptor) Prostate Specific Membrane Antigen Helicobacter pylori ACD RNA ISH Probe (concentrate) HPV-31 (RS7862) Villin ACD RNA ISH Probe Albumin ACD RNA ISH Probe (concentrate) HPV-11 (RS7860) ACD RNA ISH Probe (concentrate) HPV-18 (RS7861) ACD RNA ISH Probe EBV ACD RNA ISH Probe PPIB (Positive Control) Alpha-Sarcoglycan (Adhalin) (liquid primary antibody) Beta-Dystroglycan Spectrin (recommended for human use) Beta-Sarcoglycan (liquid primary antibody) Merosin Laminin Alpha 2 Chain Dystrophin (C-terminus) Utrophin (N-terminus) Sarcoglycan - Delta Dystrophin (Rod Domain) Emerin Sarcoglycan - Gamma Dystrophin (N-terminus) Dysferlin 2 Dysferlin 08Q006B550 40V016V495 13Q001I550 KI-20008B KI-20009R 10C003C415 KI-20010R 15Q001I550 17C006B495 KI-20017G 04Q003C550 04Q002C495 KI-20011B 07C001B495 18Q004V550 07P001C495 23P002C550 03Q003B495 10Q008V550 19P003B550 40V033V495 02P005B495 EWSR1 (22q12) Proximal - XL DDIT3 (12q13) Distal - XL 02P002B550 05P001I495 21Q003I550 11Q003I495 16Q001B495 KI-20023B 08P003B550 04C001B495 13Q002J415 17Q002B550 02P009V550 11Q005I550 08P001B495 13Q004I495 07Q001C550 04Q004C415 SS18 (18q11) Distal - XL 10Q007V495 03Q006C415 KI-20012R 03Q010V550 04C002C550 12C001C495 06Q006V495 07C004D530 20Q003B550 04P001I495 40V000V495 10Q001B495 08Q007V495 40V018V495 14Q005V495 08C002I495 KI-20001R 09Q003B495 KI-20007B KI-40002 16Q002I495 KI-20017B 07Q004I550 40V006V495 22Q001C495 23C001B495 17P001B550 17C003C495 15C001J495 14Q004V550 17Q004V550 07C006V495 08Q008V550 SE12 (D12Z3)-002 - XL 16Q003I550 22Q003B495 09C001J550 02P008V495 06Q003B495 12P001B495 06Q004D530 16Q001I495 03C001N415 13Q002C495 11Q002I495 KI-30001R 09Q005C550 10C001N495 40V000V000 KI-20006G KI-40001 07Q001B550 11Q001B495 EWSR1 (22q12) Distal - XL KI-20015B KI-20012B 19P002B495 KI-20018B KI-20009G 06Q001A550 20Q002B495 KI-30004R 01P001B495 DDIT3 (12q13) Proximal - XL MDM2 (12q15) - XL 22Q002B550 11Q001I495 01P003B550 02P006B550 01P001I495 13Q002C415 SE7 (D7Z1)-007 - XL 15C001C495 04Q001B550 08P004V550 17P002V550 01Q001B550 FOXO1 (13q14) Proximal - XL 07C003C415 EGFR (7p11) - XL 03Q007B550 40V011V495 14Q001B550 17P001I550 07Q004B550 06Q002B495 KI-20009B 13Q003J550 Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) Concentrated Liquid Mouse Monoclonal Antibody (Novocastra) 0.1ml NCL-ER-6F11 Class II 1ml NCL-ER-6F11 Class II Origin - Estrogen Receptor Estrogen Receptor (liquid primary antibody) Estrogen Receptor (BOND ready-to-use) HistoCore SPECTRA ST Leica BOND-MAX ST5020 ST4020 Leica BOND-III ST5010 (Autostainer XL) BOND-PRIME BOND Titration Container Inserts HistoCore CHROMAX ST BOND Titration Kit BOND Open Containers 30mL BOND Open Containers 7mL BOND ORACLE HER2 IHC System PD-L1 (7mL BOND Ready-to-Use) Topoisomerase II Alpha (liquid primary antibody) Immunoglobulin D (BOND ready to use) Tyrosinase (BOND ready-to-use) Bcl-2 Oncoprotein (BOND ready-to-use) CD3 (liquid primary antibody) Human Herpesvirus (Type 8) (BOND Ready-to-Use) 1ml NCL-L-LCA CD13 (liquid primary antibody) Cytokeratin 17 (BOND ready-to-use) Beta-Dystroglycan Lambda Light Chain (BOND ready-to-use) CD33 (liquid primary antibody) CD103 (BOND ready-to-use) Cytokeratin 5 (BOND ready-to-use) NovoLink Polymer Neuron Specific Enolase (BOND ready-to-use) Cytokeratin 20 (BOND ready-to-use) CD79a (JCB117) (Liquid Primary Antibody) Wilms' Tumor (liquid primary antibody) 0.5ml NCL-L-CD4-368 1ml NCL-L-vWF Myogenin (Myf-4) (liquid primary antibody) CD10 (BOND ready-to-use) 1ml NCL-L-GSTpi-438 1ml NCL-L-CD8-4B11 Folate Receptor Alpha (liquid primary antibody) Glial Fibrillary Acidic Protein (liquid primary antibody) p120 Catenin (BOND ready-to-use) CD45 (BOND ready-to-use) Epithelial Membrane Antigen (BOND ready-to-use) Enhancer of Zeste Homolog 2 (Drosophila) (EZH2) (6A10), (BOND Ready to Use) DOG-1 (liquid primary antibody) Inhibin A (BOND Ready-to-Use) Bond Ready-to-Use Primary Antibody Anaplastic Lymphoma Kinase (5A4) (BOND Ready-To-Use) CD2 (LFA-2) (BOND ready-to-use) Oct-2 (BOND ready-to-use) Cyclin D1 (liquid primary antibody) CD79a (JCB117), (BOND Ready to Use) Multiple Myeloma Oncogene 1 (MUM-1) (liquid primary antibody) Fascin (BOND ready-to-use) CD31 (BOND ready to use) CA19-9 (Sialyl Lewis) (BOND ready-to-use) c-erbB-2 Oncoprotein (BOND ready-to-use) (PA0983) CD21 (liquid primary antibody) ChromoPlex 1 Dual Detection - 50 Test CD2 (LFA-2) (liquid primary antibody) Terminal Deoxynucleotidyl Transferase (BOND ready-to-use) Ki67 Antigen (liquid primary antibody) Immunoglobulin A (liquid primary antibody) Carcinoembryonic Antigen (CD66e) (COL-1), (BOND Ready to Use) ChromoPlex 1 Dual Detection for BOND B Cell Specific Octamer Bind Protein-1 (BOB-1) (BOND ready-to-use) CD7-580 (Liquid Primary Antibody) Chromogranin A (Liquid Primary Antibody) Parathyroid Hormone (Liquid Primary Antibody) Carcinoembryonic Antigen (CD66e) (liquid primary antibody) 1ml NCL-L-CD71-309 Napsin A (BOND ready to use) ZAP 70 (liquid primary antibody) 1ml NCL-L-CD68 Synaptophysin (liquid primary antibody) Neurofilament 200kD (BOND ready-to-use) Glial Fibrilliary Acidic Protein (BOND ready-to-use) Negative (Rabbit) (BOND ready-to-use) CD23 (liquid primary antibody) Dystrophin (C-terminus) CD5 (BOND ready-to-use) Muscle Specific Actin (liquid primary antibody) Immunoglobulin G (RWP49), (BOND Ready to Use) CD7 (BOND ready-to-use) Perforin (liquid primary antibody) Granzyme B (BOND ready-to-use) CD11c (liquid primary antibody) Mast Cell Tryptase (BOND ready-to-use) Calcitonin (BOND ready-to-use) Placental Alkaline Phosphatase (liquid primary antibody) Thyroid Stimulating Hormone (BOND ready-to-use) Vimentin (liquid primary antibody) Tartrate-Resistant Acid Phosphatase (liquid primary antibody) 1ml NCL-L-TOPO I Pax-5 (BOND ready-to-use) Immunoglobulin D (liquid primary antibody) Spectrin (recommended for human use) CD30 (BOND ready-to-use) Cytokeratin 20 (liquid primary antibody) CD16 (liquid primary antibody) NovoLink Max Polymer Detection System Myosin Heavy Chain (smooth muscle) (BOND ready-to-use) S-100 (EP32) (BOND Ready-To-Use) Utrophin (N-terminus) Terminal Deoxynucleotidyl Transferase (liquid primary antibody) Human Chorionic Gonadotrophin (beta) (BOND ready-to-use) Bcl-6 Oncoprotein (liquid primary antibody) NovoLink Max DAB Human Follicle Stimulating Hormone (BOND ready-to-use) Myogenin (Myf-4) (BOND ready-to-use) p16 (6H12) (BOND Ready-To-Use) Myeloperoxidase (liquid primary antibody) CD15 (MMA), (BOND Ready to Use) p63 Protein (Liquid Primary Antibody) CA125 (Ovarian Cancer Antigen) (BOND ready-to-use) 1ml NCL-L-CD4-368 HMB45 (Melanoma Marker) (BOND ready-to-use) Factor XIIIa (liquid primary antibody) Tartrate-Resistant Acid Phosphatase (BOND ready-to-use) CD34 (BOND ready-to-use) CD5 (liquid primary antibody) Tyrosinase (liquid primary antibody) Cytokeratin 17 (liquid primary antibody) CD10-270 (Liquid Primary Antibody) Carcinoembryonic Antigen (CD66e) (BOND ready-to-use) Mesothelin (liquid primary antibody) CD23 (BOND ready-to-use) Chromogranin A (5H7), (BOND Ready to Use) 1ml NCL-L-MT1 Galectin-3 (BOND ready-to-use) Muramidase (Lysozyme) (BOND ready-to-use) 1ml NCL-L-CD56-504 1mL NCL-L-LANGERIN (Liquid Primary Antibody) CD141 (liquid primary antibody) Geminin (liquid primary antibody) 0.5ml NCL-L-CD19-163 Desmin (liquid primary antibody) 1ml NCL-L-CK19 CD3 (BOND ready-to-use) Thyroid Peroxidase (liquid primary antibody) MyoD1 (Rhabdomyosarcoma Marker) (liquid primary antibody) Tyrosine Hydroxylase (liquid primary antibody) Myoglobin (BOND ready-to-use) CD43 (BOND ready-to-use) Mesothelin (BOND ready-to-use) Bcl-6 Oncoprotein (BOND ready-to-use) Bond Polymer Define Detection Dystrophin (Rod Domain) Cytokeratin 19 (BOND ready-to-use) Cytokeratin (5/6/18) (liquid primary antibody) DAB Kit CD10 (liquid primary antibody) Cytokeratin 14 (liquid primary antibody) 1ml NCL-L-CD163 Protein Gene Product 9.5 (liquid primary antibody) Placental Alkaline Phophatase (BOND ready-to-use) CD19 (BOND ready-to-use) Insulin (BOND ready-to-use) Melan A (liquid primary antibody) Bcl-2 Oncoprotein (liquid primary antibody) CD138 (Syndecan-1) (BOND ready-to-use) Granzyme B (liquid primary antibody) E-Cadherin (BOND ready-to-use) BOND Ready-to-Use Primary Antibody LAG-3 (12H6) MLH1 (Mismatch Repair Protein) (ES05) (BOND Ready-To-Use) BOND Ready-to-Use Primary Antibody p40 (BC28) BOND Ready-to-Use Primary Antibody Muc-4 Glycoprotein (EPR9308) BOND Ready-to-Use Primary Antibody TIM-3 (EPR22241) BOND Ready-to-Use Primary Antibody FOXP3 (236A/E7) Protein Gene Product 9.5 (BOND ready-to-use) Cytokeratin 7 (BOND ready-to-use) DOG-1 (BOND ready-to-use) Multi-Cytokeratin (liquid primary antibody) Epithelial Membrane Antigen (liquid primary antibody) CDX2 (BOND ready-to-use) CD4 (BOND ready-to-use) Immunoglobulin G (liquid primary antibody) Cyclin D1 (EP12), (BOND Ready to Use) CA125 (Ovarian Cancer Antigen) (liquid primary antibody) Myeloperoxidase (BOND ready-to-use) Cytokeratin 8/18 (BOND ready-to-use) Multiple Myeloma Oncogene 1 (MUM-1) (BOND ready-to-use) 0.5ml NCL-L-CD1a-235 p53 Protein (DO-7) (BOND ready-to-use) c-erbB-2 Oncoprotein (BOND ready-to-use) (PA0571) Androgen Receptor (Liquid Primary Antibody) Inhibin Alpha (liquid primary antibody) CD15 (MMA) (Liquid Primary Antibody) Cytokeratin (8/18) (liquid primary antibody) Neurofilament 200kD (liquid primary antibody) Human Growth Hormone (BOND ready-to-use) Chromogranin A (BOND ready-to-use) NovoLink DAB CD117 (liquid primary antibody) Prostate Specific Antigen (BOND ready-to-use) Ki67 (BOND ready-to-use) von Willebrand Factor (36B11), (BOND Ready to Use) CD33 (BOND ready-to-use) Alpha-Methylacyl-CoA Racemase (EPMU1) (BOND Ready-To-Use) CD31 (BOND ready-to-use) Muc-5AC Glycoprotein (CLH2) (BOND Ready-to-Use) CD1a (BOND ready-to-use) CD45RO (BOND ready-to-use) Immunoglobulin M (8H6), (BOND Ready to Use) Oct-3/4 (BOND ready-to-use) Muc-6 Glycoprotein (CLH5) (BOND Ready-to-Use) Carbonic Anhydrase IX (CAIX) (liquid primary antibody) Vimentin (BOND ready-to-use) Beta-Sarcoglycan (liquid primary antibody) Dystrophin (N-terminus) Kappa Light Chain (BOND ready-to-use) CD123 (liquid primary antibody) Streptavidin-HRP CD20 (liquid primary antibody) Calcitonin (liquid primary antibody) Prostatic Acid Phosphatase (BOND ready-to-use) Cytokeratin 8 (BOND ready-to-use) Surfactant Protein A (liquid primary antibody) PAX-5 (Liquid Primary Antibody) CD8 (BOND ready-to-use) Sarcoglycan - Delta Cytokeratin 18 (liquid primary antibody) Glial Fibrillary Acidic Protein (GA5) (liquid primary antibody) 1ml NCL-L-p57 (Liquid Primary Antibody) Wilms' Tumor (BOND ready-to-use) E-Cadherin (liquid primary antibody) Bond Ready-to-Use Primary Antibody Programmed Death Ligand 1 (73-10) (BOND Ready-To-Use) Mammaglobin (BOND ready-to-use) CD56 (BOND ready-to-use) Desmin (BOND ready-to-use) Cytokeratin 14 (BOND ready-to-use) Mismatch Repair Protein (MLH1) (liquid primary antibody) Alpha-Methylacyl-CoA Racemase (AMACR, p504S) (Liquid Primary Antibody) Gross Cystic Disease Fluid Protein-15 (liquid primary antibody) Dysferlin Multi-Cytokeratin (AE1/AE3),(BOND Ready to Use) CD163 (10D6), (BOND Ready to Use) CD68 (BOND ready-to-use) CD99 (liquid primary antibody) S100 (EP32) (Liquid Primary Antibody) Muc-1 Glycoprotein (Ma695) (BOND Ready-to-Use) CD20 (BOND ready-to-use) Calretinin (CAL6) (liquid primary antibody) Thyroid Transcription Factor-1 (liquid primary antibody) Immunoglobulin M (liquid primary antibody) CD13 (38C12), (BOND Ready to Use) Bond Polymer Refine Detection Alpha Smooth Muscle Actin (SMA) (liquid primary antibody) Gross Cystic Disease Fluid Protein-15 (BOND ready-to-use) Serotonin (BOND ready-to-use) p63 Protein (7JUL) (BOND Ready-To-Use) CD11c (BOND ready-to-use) Melan A (BOND ready-to-use) CD31 (liquid primary antibody) Human HerpesVirus (Type 8) (Latent Nuclear Antigen) (Liquid Primary Antibody) Oct-3/4 (liquid primary antibody) Cytokeratin (HMW) (BOND ready-to-use) Thyroid Transcription Factor-1 (BOND ready-to-use) Mast Cell Tryptase (liquid primary antibody) Emerin Muscle Specific Actin (BOND ready-to-use) Epidermal Growth Factor Receptor (liquid primary antibody) Gastrin (BOND ready-to-use) CD57 (BOND ready-to-use) Factor XIIIa (BOND ready-to-use) Melanoma Marker (liquid primary antibody) CD1a (liquid primary antibody) Prostate Specific Antigen (liquid primary antibody) Muc-2 Glycoprotein (CCP58), (BOND Ready to Use) Carcinoembryonic Antigen (liquid primary antibody) NovoLink Max Polymer Thyroid Stimulating Hormone (liquid primary antibody) Biotinylated Secondary Antibody CD21 (BOND ready-to-use) Sarcoglycan - Gamma Cytokeratin 5 (liquid primary antibody) Calponin Basic (BOND ready-to-use) Bond Polymer Refine Red Detection EZH2 (Enhancer of Zeste Homolog 2 (Drosophila) (liquid primary antibody) Merosin Laminin Alpha 2 Chain Oct-3/4 (N1NK), (BOND Ready to Use) Lambda Light Chain (liquid primary antibody) Cytokeratin (AE1/AE3) (BOND ready-to-use) CD22 (BOND ready-to-use) BOND Ready-to-Use Primary Antibody PD-1 (CAL20) Cytokeratin 7 (liquid primary antibody) p53 Protein (DO-7) (liquid primary antibody) CD34 (liquid primary antibody) 0.5ml NCL-L-ALK Smooth Muscle Actin (BOND ready-to-use) Cytokeratin-Multi (liquid primary antibody) CD38 (liquid primary antibody) NovoLink Polymer Detection System Avidin/Biotin Blocking System Cytokeratin-Multi (4/5/6/8/10/13/18) (liquid primary antibody) CD61 (BOND ready-to-use) CD117 (BOND ready to use) Negative (Mouse) (BOND ready-to-use) Synaptophysin (BOND ready-to-use) CD19 (liquid primary antibody) CD25 (Interleukin 2 Receptor) (BOND ready-to-use) Napsin A (liquid primary antibody) Kappa Light Chain (liquid primary antibody) PMS2 (Mismatch Repair Protein) (EP51) BOND Ready-to-Use Primary Antibody CTLA-4 (CAL49) MSH2 (Mismatch Repair Protein) (79H11) MSH6 (Mismatch Repair Protein) (EP49) BOND-PRIME Polymer DAB Detection System BOND RNAscope Brown Detection BOND-PRIME Polymer AP Detection System CD8 (liquid primary antibody) c-erbB-2 Oncoprotein (BOND ready-to-use) (PA0571-U) c-erbB-2 Oncoprotein (BOND ready-to-use) (PA0983-U) Novocastra Liquid Mouse Monoclonal Antibody CD30 CD56 (liquid primary antibody) BOND Ready-to-Use Primary Antibody Beta-Catenin (17C2) CD68 (liquid primary antibody) SOX10 (7mL BOND Ready-to-Use) Langerin (liquid primary antibody) EpCAM (7mL BOND Ready-to-Use) H-Caldesmon (7mL BOND Ready-to-Use) CD163 (liquid primary antibody) GLUT1 (7mL BOND Ready-to-Use) P57 (liquid primary antibody) CD71 (liquid primary antibody) p80 Anaplastic Lymphoma Kinase (liquid primary antibody) Neurofilament 200kD (liquid Primary antibody) ChromoPlex 1 Dual Detection for BOND-PRIME IgG4 (7mL BOND Ready-to-Use) CD4 (liquid primary antibody) Novocastra Liquid Mouse Monoclonal Antibody Beta-Catenin Alpha Fetoprotein von Willebrand Factor (36B11) (liquid primary antibody) CD45 (liquid primary antibody) Arginase-1 (7mL BOND Ready-to-Use) BOND ChromoPlex II Dual Detection CD146 (liquid primary antibody) Desmoglein 3 (7mL BOND Ready-to-Use) BOND Ready-to-Use Primary Antibody Calretinin (CAL6) Novocastra Liquid Mouse Monoclonal Antibody c-erbB-2 Oncoprotein Podoplanin (7mL BOND Ready-to-Use) LEF-1 (7mL BOND Ready-to-Use) SOX10 (30mL BOND Ready-to-Use) Novocastra Liquid Mouse Monoclonal Antibody Terminal Deoxynucleotidyl Transferase BOND Ready-to-Use (RTU) Primary Antibody, MLH1 (Mismatch Repair Protein) (ES05) BOND Ready-to-Use (RTU) Primary Antibody, PMS2 (Mismatch Repair Protein) (EP51) BOND Ready-to-Use (RTU) Primary Antibody, MSH2 (Mismatch Repair Protein) (79H11) BOND Ready-to-Use (RTU) Primary Antibody, MSH6 (Mismatch Repair Protein) (EP49)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2017-04-19
MVU	Reagents, Specific, Analyte	Pathology	Class 1	864.4020	2017-04-19
MYA	Immunohistochemistry Antibody Assay, Estrogen Receptor	Hematology	Class 2	864.1860	2020-04-02
MXZ	Immunohistochemistry Assay, Antibody, Progesterone Receptor	Hematology	Class 2	864.1860	2020-03-19
MYA	Immunohistochemistry Antibody Assay, Estrogen Receptor	Hematology	Class 2	864.1860	2017-04-19
KPA	Slide Stainer, Automated	Pathology	Class 1	864.3800	2017-02-23
MVC	System, Test, Her-2/Neu, Ihc	Unknown	Class 3	N/A	2017-04-19
NJT	Immunohistochemistry Reagents And Kits	Hematology	Class 1	864.1860	2017-04-19
PZJ	Lynch Syndrome Test System	Immunology	Class 2	864.1866	2023-02-24

Official Correspondent

Adam Blunier

US Agent Details

Adam Blunier Business: Leica Biosystems, division of Leica Microsystems, Inc. Email: Adam.Blunier@leicabiosystems.com Phone: (630) 6340069

Related Public Records

Same Entity

Leica Biosystems, division of Leica Microsystems, 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
3006791373	Leica Biosystems Imaging, Inc.	Vista, CA, US
8020030	LEICA BIOSYSTEMS MELBOURNE PTY LTD	MELBOURNE Victoria, AU
8010478	LEICA BIOSYSTEMS NUSSLOCH GMBH	NUSSLOCH Baden-Wurttemberg, DE
3006610913	LEICA MICROSYSTEMS LTD SHANGHAI	China (Shanghai) Pilot Free Trade Zone, CN
1419341	Leica Biosystems Richmond, Inc.	Richmond, IL, US

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0014-05	Zymed Laboratories Inc.	2	Mouse anti-TTF-1 concentrate used in a panel designed to differentiate between different types of cancer when used to test a patient.
Z-0015-05	Zymed Laboratories Inc.	2	Mouse anti-TTF-1 2nd Gen Predilute used in a panel designed to differentiate between different types of cancer when used to test a patient.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004859032. Last updated year: 2026. Please use registration number 3004859032 when referencing this establishment in official correspondence.