Is this your brand? Sign in to claim ownership.

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 8 of 11

Device	Model / Reference	Registries	Class	Status
Mouse Monoclonal Anti-Human MUC6(MX110) Antibody	MAB-1011 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CK7(MX053) Antibody	MAB-0828 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Pit1(MX106) Antibody	MAB-1001 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Anti-Chromogranin A(MX018) Antibody	MAB-0707 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CK19(MX054) Antibody	MAB-0829 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Bcl-6(MX042) Antibody	MAB-0746 1.0mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human CD21(MXR017) Antibody	RMA-1037 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human HBsAg(MX103) Antibody	MAB-0898 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CD31(MX032) Antibody	MAB-0720 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human MLH1(MX063) Antibody	MAB-0838 1.0mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human Androgen Receptor/AR(MXR023) Antibody	RMA-1055 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human TTF-1(MX011) Antibody	MAB-0677 90mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human Trop2 (TACSTD2)(MXR033) Antibody	RMA-1073 1.0mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human C-erbB-2(MXR011) Antibody	RMA-1022 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CD10(MX002) Antibody	MAB-0668 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CK18(MX035) Antibody	MAB-0737 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human MSH6(MX056) Antibody	MAB-0831 0.2mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human CD4(MXR036) Antibody	RMA-1086 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human TdT(MX010) Antibody	MAB-0676 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human HBsAg(MX103) Antibody	MAB-0898 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Actin (Muscle Specific)(MX083) Antibody	MAB-0871 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human MyoD1(MX049) Antibody	MAB-0822 0.2mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human Trop2 (TACSTD2)(MXR033) Antibody	RMA-1073 0.2mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human C-met(MXR039) Antibody	RMA-1089 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Thyroid Peroxidase(TPO)(MX113) Antibody	MAB-1018 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Human Growth Hormone(GH)(MX091) Antibody	MAB-0883 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human ATRX(MX071) Antibody	MAB-0855 10mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human AMACR/P504S(MXR012) Antibody	RMA-1023 1.0mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human CDX2(MXR024) Antibody	RMA-1056 1.0mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human AMACR/P504S(MXR012) Antibody	RMA-1023 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Napsin A(MX015) Antibody	MAB-0704 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CA125(MX055) Antibody	MAB-0830 0.2mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human Claudin18.2(MXR038) Antibody	RMA-1088 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CD8(MX117) Antibody	MAB-1031 0.2mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human Androgen Receptor/AR(MXR023) Antibody	RMA-1055 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Ep-CAM(MX066) Antibody	MAB-0850 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human PRL(MX094) Antibody	MAB-0886 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Glypican-3(MAXIM001) Antibody	MAB-0667 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CD10(MX002) Antibody	MAB-0668 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human P63(MX013) Antibody	MAB-0694 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human PSMA(MX095) Antibody	MAB-0887 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Follicle-Stimulating Hormone (FSH)(MX116) Antibody	MAB-1029 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human MGMT(MX114) Antibody	MAB-1026 90mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human Estrogen Receptor(MXR030) Antibody	RMA-1065 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human HE4(MX051) Antibody	MAB-0826 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Thyroid Peroxidase(TPO)(MX113) Antibody	MAB-1018 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human PLAP(MX112) Antibody	MAB-1013 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CD19(MX016) Antibody	MAB-0705 10mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human CD117(MXR037) Antibody	RMA-1087 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CK20(MX059) Antibody	MAB-0834 1.0mL	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Fuzhou Maixin Biotech Co., Ltd. Fuzhou City Fujian · CN FEI 3030509363