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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 5 of 11

Device	Model / Reference	Registries	Class	Status
Mouse Monoclonal Anti-Human PD-1(MX033) Antibody	MAB-0734 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Podoplanin(MX025) Antibody	MAB-0714 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Bcl-6(MX042) Antibody	MAB-0746 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Galectin-3(MX060) Antibody	MAB-0835 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human MNDA(MX122) Antibody	MAB-1071 0.2mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human CD79a(MXR020) Antibody	RMA-1052 10mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human STAT6(MXR031) Antibody	RMA-1066 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CK7(MX053) Antibody	MAB-0828 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Calretinin(MX027) Antibody	MAB-0716 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CD68(MX075) Antibody	MAB-0863 0.2mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human Cytokeratin 5(MXR029) Antibody	RMA-1064 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Calretinin(MX027) Antibody	MAB-0716 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human PRL(MX094) Antibody	MAB-0886 1.0mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human villin(MXR040) Antibody	RMA-1090 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CD56(MX039) Antibody	MAB-0743 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human MUC6(MX110) Antibody	MAB-1011 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Smooth Muscle Actin(MX097) Antibody	MAB-0890 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CA125(MX055) Antibody	MAB-0830 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human OCT3/4(MX084) Antibody	MAB-0874 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human ALK(MX064) Antibody	MAB-0848 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Actin (Muscle Specific)(MX083) Antibody	MAB-0871 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CD3(MX036) Antibody	MAB-0740 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human MSH6(MX056) Antibody	MAB-0831 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CD2(MX074) Antibody	MAB-0862 10mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human P40(MXR010) Antibody	RMA-1006 10mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human CD73 (MXR014) Antibody	RMA-1025 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Human Growth Hormone(GH)(MX091) Antibody	MAB-0883 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CK18(MX035) Antibody	MAB-0737 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CK5/6(MX040) Antibody	MAB-0744 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CD31(MX032) Antibody	MAB-0720 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human PRL(MX094) Antibody	MAB-0886 10mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human Ki67(MXR002) Antibody	RMA-0731 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human T-pit(MX102) Antibody	MAB-0897 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CD20(MX003) Antibody	MAB-0669 0.2mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human CD79a(MXR020) Antibody	RMA-1052 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CD1a(MX115) Antibody	MAB-1027 0.2mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human P40(MXR010) Antibody	RMA-1006 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CD3(MX036) Antibody	MAB-0740 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human TSH(MX090) Antibody	MAB-0882 90mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human BRG1/SMARCA4(MXR028) Antibody	RMA-1063 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CK20(MX059) Antibody	MAB-0834 10mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human Ki67(MXR002) Antibody	RMA-0731 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Follicle-Stimulating Hormone (FSH)(MX116) Antibody	MAB-1029 10mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human CK8(MXR035) Antibody	RMA-1080 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human MDM2(MX133) Antibody	MAB-1102 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Hepatocyte(MX119) Antibody	MAB-1034 10mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human STAT6(MXR031) Antibody	RMA-1066 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human MUC6(MX110) Antibody	MAB-1011 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human BTLA(MX088) Antibody	MAB-0878 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Ep-CAM(MX066) Antibody	MAB-0850 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