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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 3 of 11

Device	Model / Reference	Registries	Class	Status
Rabbit Monoclonal Anti-Human pan-TRK(MXR032) Antibody	RMA-1072 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Cytokeratin(Pan)(MX005) Antibody	MAB-0671 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human HNF1ß(MX092) Antibody	MAB-0884 1.0mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human villin(MXR040) Antibody	RMA-1090 90mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human ALK(MXR016) Antibody	RMA-1032 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human IDO1(MX085) Antibody	MAB-0875 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Pax-5(MX017) Antibody	MAB-0706 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human PSA(MX030) Antibody	MAB-0719 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human LAG3(MX100) Antibody	MAB-0893 0.2mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human Androgen Receptor/AR(MXR023) Antibody	RMA-1055 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Thyroglobulin(MX131) Antibody	MAB-1100 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human MPO(MX069) Antibody	MAB-0853 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human MDM2(MX133) Antibody	MAB-1102 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Inhibin Alpha(MX098) Antibody	MAB-0891 1.0mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human CD7(MXR018) Antibody	RMA-1038 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human MUC2 (MX127) Antibody	MAB-1085 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CD3(MX036) Antibody	MAB-0740 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human ATRX(MX071) Antibody	MAB-0855 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human MUC5AC(MX126) Antibody	MAB-1079 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human MART-1/MelanA(MX118) Antibody	MAB-1033 0.2mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human SOX10(MXR026) Antibody	RMA-1058 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Carcinoembryonic Antigen(CEA)(MX068) Antibody	MAB-0852 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human IDO1(MX085) Antibody	MAB-0875 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Synaptophysin (MX038) Antibody	MAB-0742 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Calretinin(MX027) Antibody	MAB-0716 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human HP(MX014) Antibody	MAB-0692 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CK20(MX059) Antibody	MAB-0834 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human MNDA(MX122) Antibody	MAB-1071 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human MUC2 (MX127) Antibody	MAB-1085 0.2mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human CK8(MXR035) Antibody	RMA-1080 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CD163(MX081) Antibody	MAB-0869 90mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human CD7(MXR018) Antibody	RMA-1038 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CA125(MX055) Antibody	MAB-0830 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Galectin-3(MX060) Antibody	MAB-0835 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human T-pit(MX102) Antibody	MAB-0897 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human HBcAg(MX104) Antibody	MAB-0899 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Topoisomerase II Alpha(TOPOIIα)(MX108) Antibody	MAB-1009 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Ep-CAM(MX066) Antibody	MAB-0850 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human MUM1(MX093) Antibody	MAB-0885 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human P120(MX124) Antibody	MAB-1077 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Smooth Muscle Actin(MX097) Antibody	MAB-0890 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CD38(MX044) Antibody	MAB-0755 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CK14(MX057) Antibody	MAB-0832 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Thyroglobulin(MX131) Antibody	MAB-1100 0.2mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human Progesterone Receptor(MXR008) Antibody	RMA-0895 1.0mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human CD23(MXR015) Antibody	RMA-1030 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Myosin Smooth Muscle(MX109) Antibody	MAB-1010 1.0mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human STAT6(MXR031) Antibody	RMA-1066 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human IDO1(MX085) Antibody	MAB-0875 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Stathmin(MX065) Antibody	MAB-0849 0.2mL	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