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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 1 of 11

Device	Model / Reference	Registries	Class	Status
Rabbit Monoclonal Anti-Human Ki67(MXR002) Antibody	RMA-0731 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human P16(MX007) Antibody	MAB-0673 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human HNF1ß(MX092) Antibody	MAB-0884 0.2mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human Brachyury/Bry(MXR027) Antibody	RMA-1062 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human TSH(MX090) Antibody	MAB-0882 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human BTLA(MX088) Antibody	MAB-0878 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Actin (Muscle Specific)(MX083) Antibody	MAB-0871 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CD2(MX074) Antibody	MAB-0862 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Cytokeratin8(MX004) Antibody	MAB-0670 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human PLAP(MX112) Antibody	MAB-1013 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CD8(MX117) Antibody	MAB-1031 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Napsin A(MX015) Antibody	MAB-0704 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CK17(MX058) Antibody	MAB-0833 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CK14(MX057) Antibody	MAB-0832 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Cytokeratin(Pan)(MX005) Antibody	MAB-0671 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human MSH6(MX056) Antibody	MAB-0831 1.0mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human CK8(MXR035) Antibody	RMA-1080 0.2mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human Claudin18.2(MXR038) Antibody	RMA-1088 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CK7(MX053) Antibody	MAB-0828 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CD20(MX003) Antibody	MAB-0669 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Inhibin Alpha(MX098) Antibody	MAB-0891 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Ki-67(MX006) Antibody	MAB-0672 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human DOG1(MX067) Antibody	MAB-0851 90mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human CD4(MXR036) Antibody	RMA-1086 0.2mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human Progesterone Receptor(MXR008) Antibody	RMA-0895 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CD5(MX052) Antibody	MAB-0827 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human PRL(MX094) Antibody	MAB-0886 0.2mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human C-met(MXR039) Antibody	RMA-1089 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human SDHB(MX096) Antibody	MAB-0888 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human GCDFP-15(MX120) Antibody	MAB-1035 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CD8(MX117) Antibody	MAB-1031 1.0mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human CK8(MXR035) Antibody	RMA-1080 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human P63(MX013) Antibody	MAB-0694 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Desmin(MX046) Antibody	MAB-0766 0.2mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human Estrogen Receptor(MXR030) Antibody	RMA-1065 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Anti-Chromogranin A(MX018) Antibody	MAB-0707 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CD68(MX075) Antibody	MAB-0863 1.0mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human CDX2(MXR024) Antibody	RMA-1056 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Stathmin(MX065) Antibody	MAB-0849 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Glypican-3(MAXIM001) Antibody	MAB-0667 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CD68(MX075) Antibody	MAB-0863 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Synaptophysin (MX038) Antibody	MAB-0742 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Myogenin(MX078) Antibody	MAB-0866 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Human Growth Hormone(GH)(MX091) Antibody	MAB-0883 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human MyoD1(MX049) Antibody	MAB-0822 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Thyroglobulin(MX131) Antibody	MAB-1100 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human HBcAg(MX104) Antibody	MAB-0899 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human MUC2 (MX127) Antibody	MAB-1085 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CD10(MX002) Antibody	MAB-0668 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CK18(MX035) Antibody	MAB-0737 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