Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8020030

FEI Number

3006461677

Entity Name

LEICA BIOSYSTEMS MELBOURNE PTY LTD

City/State/Country

MELBOURNE Victoria, AU

Establishment Address

495 BLACKBURN RD., MOUNT WAVERLEY, MELBOURNE Victoria 3149, AU

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

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

N/A

PMA Number

N/A

All Registered Proprietary Names

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 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 CELL-DYN SMS TEG 6s Leica Cerebro BIOPLEX 2200 Instrument

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KPA	Slide Stainer, Automated	Pathology	Class 1	864.3800	2017-02-23
NJT	Immunohistochemistry Reagents And Kits	Hematology	Class 1	864.1860	2017-04-19
GKJ	Spinner, Slide, Automated	Hematology	Class 1	864.5850	2017-02-23
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2019-12-05
JQP	Calculator/Data Processing Module, For Clinical Use	Clinical Chemistry	Class 1	862.2100	2017-02-23
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2017-02-23

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
8010478	LEICA BIOSYSTEMS NUSSLOCH GMBH	NUSSLOCH Baden-Wurttemberg, DE
3004859032	LEICA BIOSYSTEMS NEWCASTLE LTD	NEWCASTLE UPON TYNE, GB
3006610913	LEICA MICROSYSTEMS LTD SHANGHAI	China (Shanghai) Pilot Free Trade Zone, CN
1419341	Leica Biosystems Richmond, Inc.	Richmond, IL, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K924453	Organon Teknika Corp.	MULTI-CHANNEL DISCRETE ANALYZER (MDA-180)	1992-12-18
K781173	Instrumentation Laboratory CO	COMPUTER INTERFACE IL 814	1978-09-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0032-06	BIOMERIEUX, INC.	2	VeriCal Calibrator Set
Z-0042-05	Dade Behring Inc. Rte 896, Glasgow Business Community	2	DispoSystem for BCT System.Model number OVFR03. Multipurpose System for in vitro coagulation studies.
Z-0043-05	bioMerieux	2	The MDA system with MDA Antithrombin III MDA Heparin
Z-0736-04	Instrumentation Laboratory Co.	2	ACL Futura Instrument Analyzer
Z-0737-04	Instrumentation Laboratory Co.	2	ACL Advance Instrument Analyzer

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3016621374	Jiangsu Medomics Medical Technology Co., Ltd.	Nanjing Jiangsu, CN
3016438761	ABBOTT LABORATORIES	Irving, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8020030. Last updated year: 2026. Please use registration number 8020030 when referencing this establishment in official correspondence.