FDA Registration
Active
🇬🇧 United Kingdom
Mast Cell Tryptase (BOND ready-to-use)
Reg #: 3004859032
·
FEI: 3004859032
·
Expires 2025
Products
1
Proprietary Names
330
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- LEICA BIOSYSTEMS NEWCASTLE LTD
- Registration Number
- 3004859032
- FEI Number
- 3004859032
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- BALLIOL BUSINESS PARK WEST, BENTON LANE
- City
- NEWCASTLE UPON TYNE
- Country
- GB
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 |
|---|---|---|---|---|---|
| Immunohistochemistry Reagents And Kits | NJT | Class 1 | Hematology | No | 2017-04-19 |
Proprietary Names
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)
Glial Fibrilliary Acidic Protein (BOND ready-to-use)
Tartrate-Resistant Acid Phosphatase (liquid primary antibody)
1ml NCL-L-TOPO I
CD4 (BOND ready-to-use)
Immunoglobulin G (liquid primary antibody)
Cyclin D1 (EP12), (BOND Ready to Use)
CD5 (BOND ready-to-use)
CA125 (Ovarian Cancer Antigen) (liquid primary antibody)
Myeloperoxidase (BOND ready-to-use)
Perforin (liquid primary antibody)
Cytokeratin 8/18 (BOND ready-to-use)
Multiple Myeloma Oncogene 1 (MUM-1) (BOND ready-to-use)
p53 Protein (DO-7) (liquid primary antibody)
CD34 (liquid primary antibody)
0.5ml NCL-L-ALK
Cytokeratin-Multi (liquid primary antibody)
CD38 (liquid primary antibody)
NovoLink Polymer Detection System
Vimentin (liquid primary antibody)
Avidin/Biotin Blocking System
Cytokeratin-Multi (4/5/6/8/10/13/18) (liquid primary antibody)
CD1a (liquid primary antibody)
ZAP 70 (liquid primary antibody)
Cytokeratin (5/6/18) (liquid primary antibody)
1ml NCL-L-CD68
DAB Kit
CD10-270 (Liquid Primary Antibody)
NovoLink Max Polymer
CD10 (liquid primary antibody)
Synaptophysin (liquid primary antibody)
Cytokeratin 14 (liquid primary antibody)
Protein Gene Product 9.5 (liquid primary antibody)
Neurofilament 200kD (BOND ready-to-use)
Placental Alkaline Phophatase (BOND ready-to-use)
Negative (Rabbit) (BOND ready-to-use)
CD23 (liquid primary antibody)
Oct-3/4 (BOND ready-to-use)
CD7-580 (Liquid Primary Antibody)
Chromogranin A (Liquid Primary Antibody)
Vimentin (BOND ready-to-use)
Parathyroid Hormone (Liquid Primary Antibody)
1ml NCL-L-CD71-309
Napsin A (BOND ready to use)
0.5ml NCL-L-CD1a-235
p53 Protein (DO-7) (BOND ready-to-use)
Human HerpesVirus (Type 8) (Latent Nuclear Antigen) (Liquid Primary Antibody)
c-erbB-2 Oncoprotein (BOND ready-to-use) (PA0571)
Androgen Receptor (Liquid Primary Antibody)
CD15 (MMA) (Liquid Primary Antibody)
Cytokeratin (8/18) (liquid primary antibody)
Epithelial Membrane Antigen (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)
Oct-2 (BOND ready-to-use)
Cyclin D1 (liquid primary antibody)
Cytokeratin 7 (liquid primary antibody)
CD79a (JCB117), (BOND Ready to Use)
Multiple Myeloma Oncogene 1 (MUM-1) (liquid primary antibody)
Smooth Muscle Actin (BOND ready-to-use)
Fascin (BOND ready-to-use)
CD31 (BOND ready to use)
c-erbB-2 Oncoprotein (BOND ready-to-use) (PA0983)
S-100 (EP32) (BOND Ready-To-Use)
Mast Cell Tryptase (liquid primary antibody)
Muscle Specific Actin (BOND ready-to-use)
Epidermal Growth Factor Receptor (liquid primary antibody)
CA19-9 (Sialyl Lewis) (BOND ready-to-use)
CD57 (BOND ready-to-use)
Factor XIIIa (BOND ready-to-use)
Melanoma Marker (liquid primary antibody)
CA125 (Ovarian Cancer Antigen) (BOND ready-to-use)
1ml NCL-L-CD4-368
HMB45 (Melanoma Marker) (BOND ready-to-use)
1ml NCL-L-CD8-4B11
Factor XIIIa (liquid primary antibody)
CD34 (BOND ready-to-use)
CD5 (liquid primary antibody)
CD10 (BOND ready-to-use)
1ml NCL-L-GSTpi-438
Mismatch Repair Protein (MLH1) (liquid primary antibody)
Folate Receptor Alpha (liquid primary antibody)
Glial Fibrillary Acidic Protein (liquid primary antibody)
Multi-Cytokeratin (AE1/AE3),(BOND Ready to Use)
CD19 (BOND ready-to-use)
Insulin (BOND ready-to-use)
p120 Catenin (BOND ready-to-use)
Melan A (liquid primary antibody)
Cytokeratin 20 (BOND ready-to-use)
CD45 (BOND ready-to-use)
Bcl-2 Oncoprotein (liquid primary antibody)
CD138 (Syndecan-1) (BOND ready-to-use)
Granzyme B (liquid primary antibody)
0.5ml NCL-L-CD4-368
E-Cadherin (BOND ready-to-use)
Myoglobin (BOND ready-to-use)
CD43 (BOND ready-to-use)
Mesothelin (BOND ready-to-use)
Cytokeratin 8 (BOND ready-to-use)
Bcl-6 Oncoprotein (BOND ready-to-use)
Bond Polymer Define Detection
Dystrophin (Rod Domain)
Cytokeratin 19 (BOND ready-to-use)
Dystrophin (C-terminus)
Muscle Specific Actin (liquid primary antibody)
Immunoglobulin G (RWP49), (BOND Ready to Use)
CD7 (BOND ready-to-use)
Epithelial Membrane Antigen (liquid primary antibody)
Granzyme B (BOND ready-to-use)
CD11c (liquid primary antibody)
Topoisomerase II Alpha (liquid primary antibody)
Immunoglobulin D (BOND ready to use)
Tyrosinase (BOND ready-to-use)
Spectrin (recommended for human use)
Bcl-2 Oncoprotein (BOND ready-to-use)
CD3 (liquid primary antibody)
CD16 (liquid primary antibody)
Human Herpesvirus (Type 8) (BOND Ready-to-Use)
1ml NCL-L-LCA
Muc-1 Glycoprotein (Ma695) (BOND Ready-to-Use)
Tyrosinase (liquid primary antibody)
Cytokeratin 17 (liquid primary antibody)
Thyroid Transcription Factor-1 (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)
Calponin Basic (BOND ready-to-use)
Bond Polymer Refine Red Detection
Merosin Laminin Alpha 2 Chain
Oct-3/4 (N1NK), (BOND Ready to Use)
Cytokeratin (AE1/AE3) (BOND ready-to-use)
CD22 (BOND ready-to-use)
Calcitonin (liquid primary antibody)
Prostatic Acid Phosphatase (BOND ready-to-use)
Enhancer of Zeste Homolog 2 (Drosophila) (EZH2) (6A10), (BOND Ready to Use)
Surfactant Protein A (liquid primary antibody)
PAX-5 (Liquid Primary Antibody)
CD2 (LFA-2) (BOND ready-to-use)
CD8 (BOND ready-to-use)
Sarcoglycan - Delta
Muc-6 Glycoprotein (CLH5) (BOND Ready-to-Use)
Carbonic Anhydrase IX (CAIX) (liquid primary antibody)
Beta-Sarcoglycan (liquid primary antibody)
Dystrophin (N-terminus)
Kappa Light Chain (BOND ready-to-use)
CD123 (liquid primary antibody)
Tartrate-Resistant Acid Phosphatase (BOND ready-to-use)
Streptavidin-HRP
CD20 (liquid primary antibody)
ChromoPlex 1 Dual Detection - 50 Test
CD2 (LFA-2) (liquid primary antibody)
Terminal Deoxynucleotidyl Transferase (BOND ready-to-use)
1ml NCL-L-p57 (Liquid Primary Antibody)
Ki67 Antigen (liquid primary antibody)
Immunoglobulin A (liquid primary antibody)
Carcinoembryonic Antigen (CD66e) (COL-1), (BOND Ready to Use)
Bond Ready-to-Use Primary Antibody Programmed Death Ligand 1 (73-10) (BOND Ready-To-Use)
ChromoPlex 1 Dual Detection for BOND
B Cell Specific Octamer Bind Protein-1 (BOB-1) (BOND ready-to-use)
CD33 (BOND ready-to-use)
Alpha-Methylacyl-CoA Racemase (EPMU1) (BOND Ready-To-Use)
Beta-Dystroglycan
CD31 (BOND ready-to-use)
CD1a (BOND ready-to-use)
CD45RO (BOND ready-to-use)
Immunoglobulin M (8H6), (BOND Ready to Use)
BOND Ready-to-Use Primary Antibody p40 (BC28)
Cytokeratin 18 (liquid primary antibody)
Glial Fibrillary Acidic Protein (GA5) (liquid primary antibody)
Wilms' Tumor (BOND ready-to-use)
E-Cadherin (liquid primary antibody)
Carcinoembryonic Antigen (CD66e) (liquid primary antibody)
Mammaglobin (BOND ready-to-use)
CD56 (BOND ready-to-use)
BOND Ready-to-Use Primary Antibody LAG-3 (12H6)
S100 (EP32) (Liquid Primary Antibody)
CD21 (liquid primary antibody)
1ml NCL-L-MT1
Galectin-3 (BOND ready-to-use)
Muramidase (Lysozyme) (BOND ready-to-use)
1ml NCL-L-CD56-504
CD141 (liquid primary antibody)
Geminin (liquid primary antibody)
Terminal Deoxynucleotidyl Transferase (liquid primary antibody)
Human Chorionic Gonadotrophin (beta) (BOND ready-to-use)
NovoLink Max DAB
Human Follicle Stimulating Hormone (BOND ready-to-use)
Myogenin (Myf-4) (BOND ready-to-use)
1ml NCL-L-CD163
p16 (6H12) (BOND Ready-To-Use)
Myeloperoxidase (liquid primary antibody)
CD15 (MMA), (BOND Ready to Use)
CD20 (BOND ready-to-use)
Calretinin (CAL6) (liquid primary antibody)
Desmin (BOND ready-to-use)
Immunoglobulin M (liquid primary antibody)
CD13 (38C12), (BOND Ready to Use)
Bond Polymer Refine Detection
Cytokeratin 14 (BOND ready-to-use)
Inhibin Alpha (liquid primary antibody)
Alpha-Methylacyl-CoA Racemase (AMACR, p504S) (Liquid Primary Antibody)
Gross Cystic Disease Fluid Protein-15 (liquid primary antibody)
Alpha Smooth Muscle Actin (SMA) (liquid primary antibody)
Dysferlin
CD163 (10D6), (BOND Ready to Use)
Gross Cystic Disease Fluid Protein-15 (BOND ready-to-use)
Serotonin (BOND ready-to-use)
CD68 (BOND ready-to-use)
CD99 (liquid primary antibody)
CD61 (BOND ready-to-use)
Negative (Mouse) (BOND ready-to-use)
Synaptophysin (BOND ready-to-use)
CD25 (Interleukin 2 Receptor) (BOND ready-to-use)
Napsin A (liquid primary antibody)
Kappa Light Chain (liquid primary antibody)
NovoLink Polymer
Neuron Specific Enolase (BOND ready-to-use)
CD79a (JCB117) (Liquid Primary Antibody)
Wilms' Tumor (liquid primary antibody)
1mL NCL-L-LANGERIN (Liquid Primary Antibody)
1ml NCL-L-vWF
Myogenin (Myf-4) (liquid primary antibody)
CD13 (liquid primary antibody)
Cytokeratin 17 (BOND ready-to-use)
EZH2 (Enhancer of Zeste Homolog 2 (Drosophila) (liquid primary antibody)
Lambda Light Chain (BOND ready-to-use)
CD33 (liquid primary antibody)
CD103 (BOND ready-to-use)
Lambda Light Chain (liquid primary antibody)
0.5ml NCL-L-CD19-163
Cytokeratin 5 (BOND ready-to-use)
Desmin (liquid primary antibody)
1ml NCL-L-CK19
CD3 (BOND ready-to-use)
Emerin
Thyroid Peroxidase (liquid primary antibody)
MyoD1 (Rhabdomyosarcoma Marker) (liquid primary antibody)
Gastrin (BOND ready-to-use)
Tyrosine Hydroxylase (liquid primary antibody)
Utrophin (N-terminus)
Protein Gene Product 9.5 (BOND ready-to-use)
Cytokeratin 7 (BOND ready-to-use)
DOG-1 (BOND ready-to-use)
Bcl-6 Oncoprotein (liquid primary antibody)
Multi-Cytokeratin (liquid primary antibody)
CDX2 (BOND ready-to-use)
CD11c (BOND ready-to-use)
Melan A (BOND ready-to-use)
CD31 (liquid primary antibody)
CD117 (BOND ready to use)
Oct-3/4 (liquid primary antibody)
Cytokeratin (HMW) (BOND ready-to-use)
CD19 (liquid primary antibody)
Thyroid Transcription Factor-1 (BOND ready-to-use)
Pax-5 (BOND ready-to-use)
Immunoglobulin D (liquid primary antibody)
Chromogranin A (BOND ready-to-use)
CD30 (BOND ready-to-use)
Cytokeratin 20 (liquid primary antibody)
Prostate Specific Antigen (BOND ready-to-use)
NovoLink Max Polymer Detection System
Myosin Heavy Chain (smooth muscle) (BOND ready-to-use)
MLH1 (Mismatch Repair Protein) (ES05) (BOND Ready-To-Use)
Prostate Specific Antigen (liquid primary antibody)
Muc-2 Glycoprotein (CCP58), (BOND Ready to Use)
Carcinoembryonic Antigen (liquid primary antibody)
Thyroid Stimulating Hormone (liquid primary antibody)
Biotinylated Secondary Antibody
CD21 (BOND ready-to-use)
Muc-5AC Glycoprotein (CLH2) (BOND Ready-to-Use)
Sarcoglycan - Gamma
Cytokeratin 5 (liquid primary antibody)
PMS2 (Mismatch Repair Protein) (EP51)
Neurofilament 200kD (liquid primary antibody)
Human Growth Hormone (BOND ready-to-use)
NovoLink DAB
CD117 (liquid primary antibody)
Ki67 (BOND ready-to-use)
von Willebrand Factor (36B11), (BOND Ready to Use)
p63 Protein (7JUL) (BOND Ready-To-Use)
p63 Protein (Liquid Primary Antibody)
BOND Ready-to-Use Primary Antibody FOXP3 (236A/E7)
MSH2 (Mismatch Repair Protein) (79H11)
MSH6 (Mismatch Repair Protein) (EP49)
BOND Ready-to-Use Primary Antibody PD-1 (CAL20)
BOND Ready-to-Use Primary Antibody CTLA-4 (CAL49)
BOND Ready-to-Use Primary Antibody Muc-4 Glycoprotein (EPR9308)
BOND Ready-to-Use Primary Antibody TIM-3 (EPR22241)
BOND RNAscope Brown Detection
BOND-PRIME Polymer AP Detection System
BOND-PRIME Polymer DAB Detection System
P57 (liquid primary antibody)
CD8 (liquid primary antibody)
Neurofilament 200kD (liquid Primary antibody)
c-erbB-2 Oncoprotein (BOND ready-to-use) (PA0983-U)
von Willebrand Factor (36B11) (liquid primary antibody)
CD56 (liquid primary antibody)
CD68 (liquid primary antibody)
Langerin (liquid primary antibody)
CD71 (liquid primary antibody)
Novocastra Liquid Mouse Monoclonal Antibody Beta-Catenin
Desmoglein 3 (7mL BOND Ready-to-Use)
CD45 (liquid primary antibody)
CD163 (liquid primary antibody)
CD4 (liquid primary antibody)
c-erbB-2 Oncoprotein (BOND ready-to-use) (PA0571-U)
EpCAM (7mL BOND Ready-to-Use)
SOX10 (30mL BOND Ready-to-Use)
LEF-1 (7mL BOND Ready-to-Use)
H-Caldesmon (7mL BOND Ready-to-Use)
Novocastra Liquid Mouse Monoclonal Antibody Terminal Deoxynucleotidyl Transferase
BOND Ready-to-Use Primary Antibody Beta-Catenin (17C2)
Podoplanin (7mL BOND Ready-to-Use)
CD146 (liquid primary antibody)
GLUT1 (7mL BOND Ready-to-Use)
Novocastra Liquid Mouse Monoclonal Antibody CD30
Novocastra Liquid Mouse Monoclonal Antibody c-erbB-2 Oncoprotein
ChromoPlex 1 Dual Detection for BOND-PRIME
p80 Anaplastic Lymphoma Kinase (liquid primary antibody)
BOND Ready-to-Use Primary Antibody Calretinin (CAL6)
Alpha Fetoprotein
BOND ChromoPlex II Dual Detection
SOX10 (7mL BOND Ready-to-Use)
Arginase-1 (7mL BOND Ready-to-Use)
IgG4 (7mL BOND Ready-to-Use)
Establishment Types
Manufacture Medical Device