FDA Registration
Active
🇦🇺 Australia
LEICA BIOSYSTEMS MELBOURNE PTY LTD
Reg #: 8020030
·
FEI: 3006461677
·
Expires 2026
Products
9
Proprietary Names
360
Establishment Types
3
Classifications
9
Registration Details
- Registration Name
- LEICA BIOSYSTEMS MELBOURNE PTY LTD
- Registration Number
- 8020030
- FEI Number
- 3006461677
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 495 BLACKBURN RD., MOUNT WAVERLEY
- City
- MELBOURNE Victoria
- Country
- AU
Owner / Operator
- Firm Name
- Leica Biosystems, division of Leica Microsystems, Inc.
- Operator Number
- 10054155
- Address
- 21440 W. Lake Cook Road, Floor 5
- City
- Deer Park
- State
- IL
- Postal Code
- 60010
- Country
- US
- Correspondent
- Adam Blunier
US Agent
- Business Name
- Leica Biosystems, division of Leica Microsystems, Inc.
- Contact Name
- Adam Blunier
- Address
- 21440 W. Lake Cook Road, Floor 5
- City
- Deer Park
- State
- IL
- ZIP
- 60010
- Country
- US
- [email protected]
- Phone
- 630 6340069 ext. 3462
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Slide Stainer, Automated | KPA | Class 1 | Pathology | No | 2017-02-23 |
| Immunohistochemistry Reagents And Kits | NJT | Class 1 | Hematology | No | 2017-04-19 |
| Spinner, Slide, Automated | GKJ | Class 1 | Hematology | No | 2017-02-23 |
| System, Multipurpose For In Vitro Coagulation Studies | JPA | Class 2 | Hematology | No | 2019-12-05 |
| Calculator/Data Processing Module, For Clinical Use | JQP | Class 1 | Clinical Chemistry | No | 2017-02-23 |
| Instrumentation For Clinical Multiplex Test Systems | NSU | Class 2 | Clinical Chemistry | No | 2017-02-23 |
| Block, Heating | JRG | Class 1 | Clinical Chemistry | No | 2017-06-23 |
| System, Automated Platelet Aggregation | JOZ | Class 2 | Hematology | No | 2017-02-23 |
| Processor, Tissue, Automated | IEO | Class 1 | Pathology | No | 2017-02-23 |
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
Thermobrite Elite
Thermobrite
ASP300S
HistoCore PEARL
TP1020
PELORIS
Leica PELORIS II
HistoCore PELORIS 3
ASP200S
ASP6025
ASP6025 S
HistoCore PEGASUS
HistoCore PEGASUS Plus
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Develop Specifications But Do Not Manufacture At This Facility