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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 2 of 11

Device	Model / Reference	Registries	Class	Status
Rabbit Monoclonal Anti-Human P40(MXR010) Antibody	RMA-1006 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human HP(MX014) Antibody	MAB-0692 90mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human ALK(MXR016) Antibody	RMA-1032 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CK14(MX057) Antibody	MAB-0832 0.2mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human AMACR/P504S(MXR012) Antibody	RMA-1023 0.2mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human ERG(MXR004) Antibody	RMA-0748 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Hepatocyte(MX119) Antibody	MAB-1034 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CD56(MX039) Antibody	MAB-0743 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Cytokeratin8(MX004) Antibody	MAB-0670 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human P63(MX013) Antibody	MAB-0694 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Smooth Muscle Actin(MX097) Antibody	MAB-0890 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human HBcAg(MX104) Antibody	MAB-0899 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human GCDFP-15(MX120) Antibody	MAB-1035 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Calponin(MX023) Antibody	MAB-0712 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human VISTA(MX086) Antibody	MAB-0876 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human SALL4(MX128) Antibody	MAB-1093 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human nm23(MX050) Antibody	MAB-0825 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Podoplanin(MX025) Antibody	MAB-0714 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human TdT(MX010) Antibody	MAB-0676 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human ALK(MX064) Antibody	MAB-0848 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Stathmin(MX065) Antibody	MAB-0849 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Ki-67(MX006) Antibody	MAB-0672 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CD68(MX075) Antibody	MAB-0863 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human E-Cadherin(MX020) Antibody	MAB-0738 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CK17(MX058) Antibody	MAB-0833 90mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human Brachyury/Bry(MXR027) Antibody	RMA-1062 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Hepatocyte(MX119) Antibody	MAB-1034 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human MUC6(MX110) Antibody	MAB-1011 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human MGMT(MX114) Antibody	MAB-1026 1.0mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human pan-TRK(MXR032) Antibody	RMA-1072 1.0mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human CD117(MXR037) Antibody	RMA-1087 1.0mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human Claudin18.2(MXR038) Antibody	RMA-1088 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human ALK(MX064) Antibody	MAB-0848 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Synaptophysin (MX038) Antibody	MAB-0742 10mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human CD21(MXR017) Antibody	RMA-1037 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human MSH6(MX056) Antibody	MAB-0831 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CD34(MX123) Antibody	MAB-1076 10mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human S100(MXR034) Antibody	RMA-1075 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human DOG1(MX067) Antibody	MAB-0851 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CD35(MX101) Antibody	MAB-0896 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Myogenin(MX078) Antibody	MAB-0866 0.2mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human BRG1/SMARCA4(MXR028) Antibody	RMA-1063 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human T-pit(MX102) Antibody	MAB-0897 10mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human Pax-8(MXR013) Antibody	RMA-1024 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CD163(MX081) Antibody	MAB-0869 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human LAG3(MX100) Antibody	MAB-0893 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human WT1(MX012) Antibody	MAB-0678 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Myogenin(MX078) Antibody	MAB-0866 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human SALL4(MX128) Antibody	MAB-1093 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human PLAP(MX112) Antibody	MAB-1013 10mL	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