FDA.reportPublic FDA data

Mouse Monoclonal Anti-Human Galectin-3(MX060) Antibody

Primary DI
06931988308489
Brand
Mouse Monoclonal Anti-Human Galectin-3(MX060) Antibody
Company
Fuzhou Maixin Biotech Co., Ltd.
Model
MAB-0835 1.0mL
Published
2024-01-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
NJTImmunohistochemistry Reagents And Kits

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NJTImmunohistochemistry Reagents And KitsHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06931988308489PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06931988308489069319883084896931988308489

GMDN Terms#

Term, Definition table
TermDefinition
Galectin-3 IVD, antibodyOne or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of galectin-3 protein in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
420499410
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06931988328678Rabbit Monoclonal Anti-Human ALK(MXR016) AntibodyRMA-1032 10mL2024-02-01
06931988328685Mouse Monoclonal Anti-Human ALK(MX064) AntibodyMAB-0848 10mL2024-02-01
06931988328692Rabbit Monoclonal Anti-Human AMACR/P504S(MXR012) AntibodyRMA-1023 10mL2024-02-01
06931988328708Rabbit Monoclonal Anti-Human Androgen Receptor/AR(MXR023) AntibodyRMA-1055 10mL2024-02-01
06931988328746Rabbit Monoclonal Anti-Human Beta-Catenin(MXR022) AntibodyRMA-1054 10mL2024-02-01
06931988328753Rabbit Monoclonal Anti-Human Brachyury/Bry(MXR027) AntibodyRMA-1062 10mL2024-02-01
06931988328845Mouse Monoclonal Anti-Human CD1a(MX115) AntibodyMAB-1027 10mL2024-02-01
06931988328869Rabbit Monoclonal Anti-Human CD21(MXR017) AntibodyRMA-1037 10mL2024-02-01
06931988328876Rabbit Monoclonal Anti-Human CD23(MXR015) AntibodyRMA-1030 10mL2024-02-01
06931988328906Mouse Monoclonal Anti-Human CD34(MX123) AntibodyMAB-1076 10mL2024-02-01
06931988328913Rabbit Monoclonal Anti-Human CD35(MXR021) AntibodyRMA-1053 10mL2024-02-01
06931988328920Mouse Monoclonal Anti-Human CD35(MX101) AntibodyMAB-0896 10mL2024-02-01
06931988328951Rabbit Monoclonal Anti-Human CD4(MXR036) AntibodyRMA-1086 10mL2024-02-01
06931988328968Mouse Monoclonal Anti-Human CD56(MX039) AntibodyMAB-0743 10mL2024-02-01
06931988328999Mouse Monoclonal Anti-Human CD68(MX075) AntibodyMAB-0863 10mL2024-02-01
06931988329002Rabbit Monoclonal Anti-Human CD73 (MXR014) AntibodyRMA-1025 10mL2024-02-01
06931988329019Rabbit Monoclonal Anti-Human CD79a(MXR020) AntibodyRMA-1052 10mL2024-02-01
06931988329026Rabbit Monoclonal Anti-Human CD7(MXR018) AntibodyRMA-1038 10mL2024-02-01
06931988329033Mouse Monoclonal Anti-Human CD8(MX117) AntibodyMAB-1031 10mL2024-02-01
06931988329040Rabbit Monoclonal Anti-Human CDX2(MXR024) AntibodyRMA-1056 10mL2024-02-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336182765VENTANA pan-TRK (EPR17341) AssayVentana Medical Systems, Inc.NJT2026-03-16
00847627042637Pan TRK [RM423]BIOCARE MEDICAL LLCNJT2026-02-19
07613336231395PAX-8 (SP348) Rabbit Monoclonal AntibodyVentana Medical Systems, Inc.NJT2026-02-16
00847627042279CK7BIOCARE MEDICAL LLCNJT2026-01-29
00847627042033DesminBIOCARE MEDICAL LLCNJT2026-01-13
00847627042835CD19BIOCARE MEDICAL LLCNJT2026-01-13
00847627041937Myeloperoxidase (P)BIOCARE MEDICAL LLCNJT2026-01-06
00847627042514VimentinBIOCARE MEDICAL LLCNJT2026-01-06
00615233011435Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.NJT2025-12-26
00615233011442Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.NJT2025-12-26
00615233013996Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.NJT2025-12-26
00615233014009Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.NJT2025-12-26
00615233014474Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.NJT2025-12-26
00615233014481Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.NJT2025-12-26
00615233014559Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.NJT2025-12-26
00615233014566Tissue-Tek Genie®SAKURA FINETEK U.S.A., INC.NJT2025-12-26
00847627042019CD43BIOCARE MEDICAL LLCNJT2025-12-16
00847627042118Cytokeratin 18 (CK18)BIOCARE MEDICAL LLCNJT2025-12-16
00847627042491CD79aBIOCARE MEDICAL LLCNJT2025-12-16
00847627042576Cytokeratin [AE1] LMWBIOCARE MEDICAL LLCNJT2025-12-16
00847627042897CD103 (RM)BIOCARE MEDICAL LLCNJT2025-12-16
04015630971176Bluing ReagentVentana Medical Systems, Inc.NJT2025-12-15
04015630971299Amplification KitVentana Medical Systems, Inc.NJT2025-12-15
04015630972128CONFIRM anti-ALK1 (ALK01) Primary AntibodyVentana Medical Systems, Inc.NJT2025-12-15
07613336158357VENTANA Red ISH DIG Detection KitVentana Medical Systems, Inc.NJT2025-12-15
07613336158418VENTANA Silver ISH DNP Detection KitVentana Medical Systems, Inc.NJT2025-12-15
00847627042071Mammaglobin (M)BIOCARE MEDICAL LLCNJT2025-11-25
00847627042132CD7BIOCARE MEDICAL LLCNJT2025-11-25
00847627042965Pan Melanoma Cocktail-2BIOCARE MEDICAL LLCNJT2025-11-17
00847627039095Desmoglein 3BIOCARE MEDICAL LLCNJT2025-09-19