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Fuzhou Maixin Biotech Co., Ltd.

Last updated May 23, 2026

What Fuzhou Maixin Biotech Co., Ltd. makes

Fuzhou Maixin Biotech Co., Ltd. manufactures in vitro diagnostic (IVD) antibodies and antibody detection kits for immunohistochemistry applications. Their products include monoclonal and polyclonal antibodies targeting specific biomarkers such as Ki67, cytokeratins, mucins, calretinin, ALK, CD35, CD68, and other tissue markers used in pathology testing.

The company's devices are classified as Class I medical devices and are listed in the FDA's Unique Device Identification (FDA UDI) system. Fuzhou Maixin Biotech Co., Ltd. is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What does Fuzhou Maixin Biotech Co., Ltd. make?

Where is Fuzhou Maixin Biotech Co., Ltd. based?

Fuzhou Maixin Biotech Co., Ltd. is based in the United States, as stated in the provided data. The company’s location is specified under the COUNTRY field as US, indicating its operational base is within the United States.

Which regulatory registries list the devices made by Fuzhou Maixin Biotech Co., Ltd.?

The devices manufactured by Fuzhou Maixin Biotech Co., Ltd. are listed in the FDA's Unique Device Identification (FDA UDI) system. This is indicated in the LISTED IN field as fda_udi, meaning their products are included in the U.S. Food and Drug Administration’s UDI database for traceability and regulatory oversight.

How are the devices made by Fuzhou Maixin Biotech Co., Ltd. classified?

The devices made by Fuzhou Maixin Biotech Co., Ltd. are classified as Class I medical devices. This classification is explicitly stated in the DEVICE CLASSES field, indicating they are subject to general controls under FDA regulations due to their low to moderate risk profile.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: —
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 420499410

Catalogue (532)

Page 7 of 11

Device	Model / Reference	Registries	Class	Status
Mouse Monoclonal Anti-Human CD1a(MX115) Antibody	MAB-1027 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human LAG3(MX100) Antibody	MAB-0893 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human GCDFP-15(MX120) Antibody	MAB-1035 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human MSH2(MX061) Antibody	MAB-0836 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Thyroglobulin(MX131) Antibody	MAB-1100 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CK5/6(MX040) Antibody	MAB-0744 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CK17(MX058) Antibody	MAB-0833 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human MSH2(MX061) Antibody	MAB-0836 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CK-HMW(MX134) Antibody	MAB-1111 1.0mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human Progesterone Receptor(MXR008) Antibody	RMA-0895 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human PLAP(MX112) Antibody	MAB-1013 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Galectin-3(MX060) Antibody	MAB-0835 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Stathmin(MX065) Antibody	MAB-0849 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Human Growth Hormone(GH)(MX091) Antibody	MAB-0883 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human T-pit(MX102) Antibody	MAB-0897 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CD31(MX032) Antibody	MAB-0720 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Bcl-2(MX022) Antibody	MAB-0711 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human PSA(MX030) Antibody	MAB-0719 0.2mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human STAT6(MXR031) Antibody	RMA-1066 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human VISTA(MX086) Antibody	MAB-0876 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human P120(MX124) Antibody	MAB-1077 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Langerin (CD207)(MX121) Antibody	MAB-1068 90mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human C-met(MXR039) Antibody	RMA-1089 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CK5/6(MX040) Antibody	MAB-0744 1.0mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human ALK(MXR016) Antibody	RMA-1032 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human BTLA(MX088) Antibody	MAB-0878 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human MUC5AC(MX126) Antibody	MAB-1079 1.0mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human CD4(MXR036) Antibody	RMA-1086 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Anti-Chromogranin A(MX018) Antibody	MAB-0707 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CD35(MX101) Antibody	MAB-0896 0.2mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human CD117(MXR037) Antibody	RMA-1087 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human P63(MX013) Antibody	MAB-0694 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CD56(MX039) Antibody	MAB-0743 90mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human Cytokeratin 5(MXR029) Antibody	RMA-1064 1.0mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human CD73 (MXR014) Antibody	RMA-1025 10mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human Estrogen Receptor(MXR030) Antibody	RMA-1065 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human TdT(MX010) Antibody	MAB-0676 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human MNDA(MX122) Antibody	MAB-1071 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human E-Cadherin(MX020) Antibody	MAB-0738 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CD19(MX016) Antibody	MAB-0705 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Myosin Smooth Muscle(MX109) Antibody	MAB-1010 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human SALL4(MX128) Antibody	MAB-1093 10mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human Beta-Catenin(MXR022) Antibody	RMA-1054 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Pit1(MX106) Antibody	MAB-1001 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CK19(MX054) Antibody	MAB-0829 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human TTF-1(MX011) Antibody	MAB-0677 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human WT1(MX012) Antibody	MAB-0678 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CD31(MX032) Antibody	MAB-0720 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Cytokeratin(Pan)(MX005) Antibody	MAB-0671 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human VISTA(MX086) Antibody	MAB-0876 1.0mL	FDA UDI	Class I	Active

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FDA Establishments (1)

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Fuzhou Maixin Biotech Co., Ltd. Fuzhou City Fujian · CN FEI 3030509363