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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 6 of 11

Device	Model / Reference	Registries	Class	Status
Mouse Monoclonal Anti-Human MLH1(MX063) Antibody	MAB-0838 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Thyroid Peroxidase(TPO)(MX113) Antibody	MAB-1018 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Smooth Muscle Actin(MX097) Antibody	MAB-0890 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human GFAP(MX047) Antibody	MAB-0769 0.2mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human CD23(MXR015) Antibody	RMA-1030 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CD61(MX037) Antibody	MAB-0741 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human MDM2(MX133) Antibody	MAB-1102 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CK14(MX057) Antibody	MAB-0832 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CD8(MX117) Antibody	MAB-1031 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CK5/6(MX040) Antibody	MAB-0744 90mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human CDX2(MXR024) Antibody	RMA-1056 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CD20(MX003) Antibody	MAB-0669 10mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human CD79a(MXR020) Antibody	RMA-1052 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Langerin (CD207)(MX121) Antibody	MAB-1068 10mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human CD7(MXR018) Antibody	RMA-1038 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Myosin Smooth Muscle(MX109) Antibody	MAB-1010 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CD34(MX123) Antibody	MAB-1076 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human P16(MX007) Antibody	MAB-0673 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CA125(MX055) Antibody	MAB-0830 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human SALL4(MX128) Antibody	MAB-1093 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CD38(MX044) Antibody	MAB-0755 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CD10(MX002) Antibody	MAB-0668 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human P120(MX124) Antibody	MAB-1077 90mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human Pax-8(MXR013) Antibody	RMA-1024 1.0mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human Progesterone Receptor(MXR008) Antibody	RMA-0895 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Pax-5(MX017) Antibody	MAB-0706 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human MPO(MX069) Antibody	MAB-0853 10mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human CD73 (MXR014) Antibody	RMA-1025 1.0mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human CD73 (MXR014) Antibody	RMA-1025 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Podoplanin(MX025) Antibody	MAB-0714 90mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human S100(MXR034) Antibody	RMA-1075 10mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human CD21(MXR017) Antibody	RMA-1037 0.2mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human Brachyury/Bry(MXR027) Antibody	RMA-1062 1.0mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human Beta-Catenin(MXR022) Antibody	RMA-1054 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Anti-Chromogranin A(MX018) Antibody	MAB-0707 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human PD-1(MX033) Antibody	MAB-0734 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Topoisomerase II Alpha(TOPOIIα)(MX108) Antibody	MAB-1009 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CK-HMW(MX134) Antibody	MAB-1111 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human P16(MX007) Antibody	MAB-0673 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Cytokeratin8(MX004) Antibody	MAB-0670 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human WT1(MX012) Antibody	MAB-0678 90mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human CD117(MXR037) Antibody	RMA-1087 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human MUM1(MX093) Antibody	MAB-0885 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human MLH1(MX063) Antibody	MAB-0838 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Topoisomerase II Alpha(TOPOIIα)(MX108) Antibody	MAB-1009 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CK19(MX054) Antibody	MAB-0829 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human MPO(MX069) Antibody	MAB-0853 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Desmin(MX046) Antibody	MAB-0766 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Podoplanin(MX025) Antibody	MAB-0714 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human GFAP(MX047) Antibody	MAB-0769 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