Question 1

What does Fuzhou Maixin Biotech Co., Ltd. make?

Accepted Answer

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.

Question 2

Where is Fuzhou Maixin Biotech Co., Ltd. based?

Accepted Answer

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.

Question 3

Which regulatory registries list the devices made by Fuzhou Maixin Biotech Co., Ltd.?

Accepted Answer

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.

Question 4

How are the devices made by Fuzhou Maixin Biotech Co., Ltd. classified?

Accepted Answer

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.

Device	Model / Reference	Registries	Class	Status
Rabbit Monoclonal Anti-Human S100(MXR034) Antibody	RMA-1075 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human DOG1(MX067) Antibody	MAB-0851 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human HBsAg(MX103) Antibody	MAB-0898 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Pit1(MX106) Antibody	MAB-1001 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human PSMA(MX095) Antibody	MAB-0887 90mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human ERG(MXR004) Antibody	RMA-0748 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CD2(MX074) Antibody	MAB-0862 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Follicle-Stimulating Hormone (FSH)(MX116) Antibody	MAB-1029 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human P120(MX124) Antibody	MAB-1077 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human nm23(MX050) Antibody	MAB-0825 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human MGMT(MX114) Antibody	MAB-1026 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CD2(MX074) Antibody	MAB-0862 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human TTF-1(MX011) Antibody	MAB-0677 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CD38(MX044) Antibody	MAB-0755 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CK7(MX053) Antibody	MAB-0828 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CD163(MX081) Antibody	MAB-0869 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human nm23(MX050) Antibody	MAB-0825 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human CD56(MX039) Antibody	MAB-0743 1.0mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human C-erbB-2(MXR011) Antibody	RMA-1022 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Inhibin Alpha(MX098) Antibody	MAB-0891 0.2mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human pan-TRK(MXR032) Antibody	RMA-1072 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human ATRX(MX071) Antibody	MAB-0855 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human MUM1(MX093) Antibody	MAB-0885 0.2mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human ALK(MXR016) Antibody	RMA-1032 1.0mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human Beta-Catenin(MXR022) Antibody	RMA-1054 90mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Carcinoembryonic Antigen(CEA)(MX068) Antibody	MAB-0852 0.2mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Ep-CAM(MX066) Antibody	MAB-0850 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human MDM2(MX133) Antibody	MAB-1102 10mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human MART-1/MelanA(MX118) Antibody	MAB-1033 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Follicle-Stimulating Hormone (FSH)(MX116) Antibody	MAB-1029 1.0mL	FDA UDI	Class I	Active
Mouse Monoclonal Anti-Human Bcl-6(MX042) Antibody	MAB-0746 0.2mL	FDA UDI	Class I	Active
Rabbit Monoclonal Anti-Human Pax-8(MXR013) Antibody	RMA-1024 0.2mL	FDA UDI	Class I	Active

Fuzhou Maixin Biotech Co., Ltd.

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