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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 9 of 11

Device	Model / Reference	Registries	Class	Status
Mouse Monoclonal Anti-Human Calponin(MX023) Antibody	MAB-0712 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Cytokeratin8(MX004) Antibody	MAB-0670 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human TSH(MX090) Antibody	MAB-0882 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Glypican-3(MAXIM001) Antibody	MAB-0667 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Glypican-3(MAXIM001) Antibody	MAB-0667 10mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human CD35(MXR021) Antibody	RMA-1053 0.2mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human Estrogen Receptor(MXR030) Antibody	RMA-1065 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human OCT3/4(MX084) Antibody	MAB-0874 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human SDHB(MX096) Antibody	MAB-0888 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Calponin(MX023) Antibody	MAB-0712 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Bcl-2(MX022) Antibody	MAB-0711 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CD5(MX052) Antibody	MAB-0827 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human BTLA(MX088) Antibody	MAB-0878 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Inhibin Alpha(MX098) Antibody	MAB-0891 90mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human villin(MXR040) Antibody	RMA-1090 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human MUC2 (MX127) Antibody	MAB-1085 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CD5(MX052) Antibody	MAB-0827 0.2mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human Cytokeratin 5(MXR029) Antibody	RMA-1064 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human MUM1(MX093) Antibody	MAB-0885 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human P16(MX007) Antibody	MAB-0673 90mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human Ki67(MXR002) Antibody	RMA-0731 1.0mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human Androgen Receptor/AR(MXR023) Antibody	RMA-1055 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Hepatocyte(MX119) Antibody	MAB-1034 90mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human CD35(MXR021) Antibody	RMA-1053 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human MPO(MX069) Antibody	MAB-0853 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human GFAP(MX047) Antibody	MAB-0769 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human MUC5AC(MX126) Antibody	MAB-1079 10mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human ERG(MXR004) Antibody	RMA-0748 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CD5(MX052) Antibody	MAB-0827 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Bcl-2(MX022) Antibody	MAB-0711 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human PD-1(MX033) Antibody	MAB-0734 10mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human BRG1/SMARCA4(MXR028) Antibody	RMA-1063 0.2mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human ERG(MXR004) Antibody	RMA-0748 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human PSA(MX030) Antibody	MAB-0719 10mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human Claudin18.2(MXR038) Antibody	RMA-1088 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human PSMA(MX095) Antibody	MAB-0887 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human GCDFP-15(MX120) Antibody	MAB-1035 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CK17(MX058) Antibody	MAB-0833 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Actin (Muscle Specific)(MX083) Antibody	MAB-0871 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Carcinoembryonic Antigen(CEA)(MX068) Antibody	MAB-0852 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CD3(MX036) Antibody	MAB-0740 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CD20(MX003) Antibody	MAB-0669 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human ALK(MX064) Antibody	MAB-0848 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Desmin(MX046) Antibody	MAB-0766 10mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human Pax-8(MXR013) Antibody	RMA-1024 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human PD-1(MX033) Antibody	MAB-0734 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human MyoD1(MX049) Antibody	MAB-0822 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CD61(MX037) Antibody	MAB-0741 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human HP(MX014) Antibody	MAB-0692 0.2mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human AMACR/P504S(MXR012) Antibody	RMA-1023 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