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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 4 of 11

Device	Model / Reference	Registries	Class	Status
Mouse Monoclonal Anti-Human WT1(MX012) Antibody	MAB-0678 0.2mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human P40(MXR010) Antibody	RMA-1006 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human HNF1ß(MX092) Antibody	MAB-0884 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CD61(MX037) Antibody	MAB-0741 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human MGMT(MX114) Antibody	MAB-1026 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Pit1(MX106) Antibody	MAB-1001 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CD35(MX101) Antibody	MAB-0896 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human IDO1(MX085) Antibody	MAB-0875 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human HE4(MX051) Antibody	MAB-0826 90mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human CD4(MXR036) Antibody	RMA-1086 90mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human CD23(MXR015) Antibody	RMA-1030 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human ATRX(MX071) Antibody	MAB-0855 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human TTF-1(MX011) Antibody	MAB-0677 1.0mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human pan-TRK(MXR032) Antibody	RMA-1072 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CD19(MX016) Antibody	MAB-0705 0.2mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human SOX10(MXR026) Antibody	RMA-1058 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Carcinoembryonic Antigen(CEA)(MX068) Antibody	MAB-0852 10mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human Cytokeratin 5(MXR029) Antibody	RMA-1064 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human LAG3(MX100) Antibody	MAB-0893 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human E-Cadherin(MX020) Antibody	MAB-0738 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human E-Cadherin(MX020) Antibody	MAB-0738 0.2mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human C-met(MXR039) Antibody	RMA-1089 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Calretinin(MX027) Antibody	MAB-0716 10mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human CD79a(MXR020) Antibody	RMA-1052 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human GFAP(MX047) Antibody	MAB-0769 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CK-HMW(MX134) Antibody	MAB-1111 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Desmin(MX046) Antibody	MAB-0766 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CD35(MX101) Antibody	MAB-0896 90mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human SOX10(MXR026) Antibody	RMA-1058 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human MSH2(MX061) Antibody	MAB-0836 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Galectin-3(MX060) Antibody	MAB-0835 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human HP(MX014) Antibody	MAB-0692 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CK-HMW(MX134) Antibody	MAB-1111 10mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human BRG1/SMARCA4(MXR028) Antibody	RMA-1063 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human HE4(MX051) Antibody	MAB-0826 10mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human SOX10(MXR026) Antibody	RMA-1058 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human PSMA(MX095) Antibody	MAB-0887 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Calponin(MX023) Antibody	MAB-0712 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CD163(MX081) Antibody	MAB-0869 10mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human CD35(MXR021) Antibody	RMA-1053 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Bcl-6(MX042) Antibody	MAB-0746 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human MyoD1(MX049) Antibody	MAB-0822 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human MLH1(MX063) Antibody	MAB-0838 90mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human CD23(MXR015) Antibody	RMA-1030 90mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human Trop2 (TACSTD2)(MXR033) Antibody	RMA-1073 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human HBsAg(MX103) Antibody	MAB-0898 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human MART-1/MelanA(MX118) Antibody	MAB-1033 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Myosin Smooth Muscle(MX109) Antibody	MAB-1010 0.2mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human S100(MXR034) Antibody	RMA-1075 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human OCT3/4(MX084) Antibody	MAB-0874 90mL	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