FUZHOU MAIXIN BIOTECH CO., LTD.

FDA Device Registration & Listing · Fuzhou City Fujian, CN · Registration 3030509363

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3030509363
FEI Number
3030509363
Entity Name
FUZHOU MAIXIN BIOTECH CO., LTD.
City/State/Country
Fuzhou City Fujian, CN
Establishment Address
No. 98, Chaipai Road, Shangjie Town, Minhou County, Fuzhou City Fujian 350108, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Fuzhou Maixin Biotech Co., Ltd. (Owner Number: 10089536)
Owner / Operator Contact Address
No. 98, Chaipai Road, Shangjie Town, Minhou County, Fuzhou City, CN-FJ 350108, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Titan S Autostaining System Titan Autostaining System p16/Ki67 Dual Staining reagent Decalcifying Solution Mouse Monoclonal Anti-Human CYP17A1(MX138) Antibody Mouse Monoclonal Anti-Human IgG4(MX151) Antibody MaxVision TM HRP(Mouse/Rabbit) IHC Kit 2 step HRP Detection Kit(For Autostaining System) Rabbit Monoclonal Anti-Human MSH6(MXR061) Antibody Mouse Monoclonal Anti-Human CD45(MX145) Antibody Rabbit Monoclonal Anti-Human Calcitonin(MXR059) Antibody Rabbit Monoclonal Anti-Human POU2F3(MXR075) Antibody Mouse Monoclonal Anti-Human BRAF V600E(MX125) Antibody Rabbit Monoclonal Anti-Human HP(MXR069) Antibody Rabbit Monoclonal Anti-Human PD-L1(MXR025) Antibody Rabbit Monoclonal Anti-Human Carcinoembryonic Antigen(CEA)(MXR058) Antibody plus DAB Kit Goat Anti-Mouse HRP DAB Kit(For Autostaining System) MaxVision TM HRP(Goat) IHC Polymer DIG Detection Kit Goat Anti-Rabbit HRP DAB Kit(For Autostaining System) Rabbit Monoclonal Anti-Human INSM1(MXR064) Antibody Rabbit Monoclonal Anti-Human TRPS1(MXR063) Antibody Hematoxylin(For Autostaining System) Buffer solution(TW) Mouse Monoclonal Anti-Human CK19(MX054) Antibody Mouse Monoclonal Anti-Human HE4(MX051) Antibody Mouse Monoclonal Anti-Human CK7(MX053) Antibody Rabbit Monoclonal Anti-Human villin(MXR040) Antibody Mouse Monoclonal Anti-Human CD1a(MX115) Antibody Rabbit Monoclonal Anti-Human BRG1/SMARCA4(MXR028) Antibody Mouse Monoclonal Anti-Human CD163(MX081) Antibody Rabbit Monoclonal Anti-Human S100(MXR034) Antibody Mouse Monoclonal Anti-Human Myogenin(MX078) Antibody Rabbit Monoclonal Anti-Human Ki67(MXR002) Antibody Mouse Monoclonal Anti-Human PLAP(MX112) Antibody Mouse Monoclonal Anti-Human MPO(MX069) Antibody Mouse Monoclonal Anti-Human CD5(MX052) Antibody Mouse Monoclonal Anti-Human Pax-5(MX017) Antibody Mouse Monoclonal Anti-Human P16(MX007) Antibody Mouse Monoclonal Anti-Human Cytokeratin(Pan)(MX005) Antibody Rabbit Monoclonal Anti-Human C-met(MXR039) Antibody Mouse Monoclonal Anti-Human MSH2(MX061) Antibody Rabbit Monoclonal Anti-Human C-erbB-2(MXR011) Antibody Rabbit Monoclonal Anti-Human CD21(MXR017) Antibody Mouse Monoclonal Anti-Human CD34(MX123) Antibody Rabbit Monoclonal Anti-Human CD7(MXR018) Antibody Rabbit Monoclonal Anti-Human CK8(MXR035) Antibody Mouse Monoclonal Anti-Human MDM2(MX133) Antibody Rabbit Monoclonal Anti-Human CD79a(MXR020) Antibody Mouse Monoclonal Anti-Human Ep-CAM(MX066) Antibody Mouse Monoclonal Anti-Human CD20(MX003) Antibody Mouse Monoclonal Anti-Human CK17(MX058) Antibody Mouse Monoclonal Anti-Human CD3(MX036) Antibody Mouse Monoclonal Anti-Human Stathmin(MX065) Antibody Mouse Monoclonal Anti-Human GCDFP-15(MX120) Antibody Mouse Monoclonal Anti-Human CK14(MX057) Antibody DAB Chromogen Mouse Monoclonal Anti-Human Galectin-3(MX060) Antibody Mouse Monoclonal Anti-Human TSH(MX090) Antibody Rabbit Monoclonal Anti-Human Progesterone Receptor(MXR008) Antibody Rabbit Monoclonal Anti-Human CD23(MXR015) Antibody Mouse Monoclonal Anti-Human HBcAg(MX104) Antibody Mouse Monoclonal Anti-Human CD61(MX037) Antibody Mouse Monoclonal Anti-Human Myosin Smooth Muscle(MX109) Antibody Mouse Monoclonal Anti-Human MUM1(MX093) Antibody Mouse Monoclonal Anti-Human Podoplanin(MX025) Antibody Mouse Monoclonal Anti-Human Langerin (CD207)(MX121) Antibody Mouse Monoclonal Anti-Human Hepatocyte(MX119) Antibody Mouse Monoclonal Anti-Human Carcinoembryonic Antigen(CEA)(MX068) Antibody Mouse Monoclonal Anti-Human TTF-1(MX011) Antibody Mouse Monoclonal Anti-Human CK18(MX035) Antibody Rabbit Monoclonal Anti-Human CD35(MXR021) Antibody Rabbit Monoclonal Anti-Human pan-TRK(MXR032) Antibody Rabbit Monoclonal Anti-Human Trop2 (TACSTD2)(MXR033) Antibody Mouse Monoclonal Anti-Human T-pit(MX102) Antibody Rabbit Monoclonal Anti-Human CD4(MXR036) Antibody Mouse Monoclonal Anti-Human CK5/6(MX040) Antibody Mouse Monoclonal Anti-Human CD10(MX002) Antibody Mouse Monoclonal Anti-Human Actin (Muscle Specific)(MX083) Antibody Rabbit Monoclonal Anti-Human Cytokeratin 5(MXR029) Antibody Mouse Monoclonal Anti-Human CD35(MX101) Antibody Mouse Monoclonal Anti-Human MyoD1(MX049) Antibody Mouse Monoclonal Anti-Human CD31(MX032) Antibody Mouse Monoclonal Anti-Human Cytokeratin8(MX004) Antibody Mouse Monoclonal Anti-Human CD19(MX016) Antibody Mouse Monoclonal Anti-Human OCT3/4(MX084) Antibody Rabbit Monoclonal Anti-Human SOX10(MXR026) Antibody Rabbit Monoclonal Anti-Human CD73 (MXR014) Antibody Mouse Monoclonal Anti-Human Glypican-3(MAXIM001) Antibody Mouse Monoclonal Anti-Human Napsin A(MX015) Antibody Mouse Monoclonal Anti-Human TdT(MX010) Antibody Mouse Monoclonal Anti-Human E-Cadherin(MX020) Antibody Rabbit Monoclonal Anti-Human Claudin18.2(MXR038) Antibody Rabbit Monoclonal Anti-Human AMACR/P504S(MXR012) Antibody Mouse Monoclonal Anti-Human MUC6(MX110) Antibody Mouse Monoclonal Anti-Human LAG3(MX100) Antibody Mouse Monoclonal Anti-Human Thyroid Peroxidase(TPO)(MX113) Antibody Rabbit Monoclonal Anti-Human Mammaglobin(MXR049) Antibody Mouse Monoclonal Anti-Human Vimentin(MX034) Antibody Antibody Diluent Mouse Monoclonal Anti-Human CD56(MX039) Antibody Mouse Monoclonal Anti-Human HNF1?(MX092) Antibody Rabbit Monoclonal Anti-Human STAT6(MXR031) Antibody Mouse Monoclonal Anti-Human Pit1(MX106) Antibody Mouse Monoclonal Anti-Human EMA(MX132) Antibody Rabbit Monoclonal Anti-Human SOX-11(MXR046) Antibody Rabbit Monoclonal Anti-Human Elastin(MXR057) Antibody Mouse Monoclonal Anti-Human ACTH(MX140) Antibody Rabbit Monoclonal Anti-Human SOX-2(MXR047) Antibody Rabbit Monoclonal Anti-Human Estrogen Receptor(MXR030) Antibody Mouse Monoclonal Anti-Human DOG1(MX067) Antibody Rabbit Monoclonal Anti-Human Beta-Catenin(MXR022) Antibody Peroxidase for SP Mouse Monoclonal Anti-Human PRL(MX094) Antibody Mouse Monoclonal Anti-Human IDO1(MX085) Antibody DAB Kit(20X) Elivision super TM (Mouse/Rabbit) IHC Kit(without chromogens) Mouse Monoclonal Anti-Human Beta-catenin(MX043) Antibody Rabbit Monoclonal Anti-Human CD155(MXR052) Antibody Rabbit Monoclonal Anti-Human ALK(MXR016) Antibody Mouse Monoclonal Anti-Human SDHB(MX096) Antibody Mouse Monoclonal Anti-Human MSH6(MX056) Antibody Mouse Monoclonal Anti-Human MART-1/MelanA(MX118) Antibody Mouse Monoclonal Anti-Human GFAP(MX047) Antibody IHC Antigen Retrieval Solution(Powdered Citric Acid) Mouse Monoclonal Anti-Human FOXP3(MX149) Antibody Rabbit Monoclonal Anti-Human Chromogranin A(MXR078) Antibody IHC Antigen Retrieval Solution(Pepsin) MaxVision DAB Normal Goat Serum Deparaffinization Solution Rabbit Monoclonal Anti-Human SS18-SSX(MXR074) Antibody Rabbit Monoclonal Anti-Human pS2(MXR062) Antibody Mouse Monoclonal Anti-Human Melanoma(MX026) Antibody Mouse Monoclonal Anti-Human TIM3(MX087) Antibody IHC Antigen Retrieval Solution(Pancreatin) Rabbit Monoclonal Anti-Human FGFR2b(MXR079) Antibody Rabbit Monoclonal Anti-Human WT1(MXR070) Antibody Mouse Monoclonal Anti-Human CD30(MX080) Antibody IHC Antigen Retrieval Solution(EDTA) Hematoxylin 1 step HRP Detection Kit(For Autostaining System) Mouse Monoclonal Anti-Human CD99(MX111) Antibody Rabbit Monoclonal Anti-Human c-MYC(MXR077) Antibody Mouse Monoclonal Anti-Human CD38(MX044) Antibody Mouse Monoclonal Anti-Human WT1(MX012) Antibody HRP DAB Kit Endogenous Peroxidase Block Rabbit Monoclonal Anti-Human CD47(MXR005) Antibody Rabbit Monoclonal Anti-Human Mesothelin(MXR055) Antibody AMACR/p63/CK HMW Dual Staining Kit p16/Ki67 Dual Staining Kit Mouse Monoclonal Anti-Human CA IX(Carbonic anhydrase IX)(MX147) Antibody Rabbit Monoclonal Anti-Human CK5/6(MXR065) Antibody Mouse Monoclonal Anti-Human Smooth Muscle Actin(MX097) Antibody Mouse Monoclonal Anti-Human CK-HMW(MX134) Antibody Rabbit Monoclonal Anti-Human CD117(MXR037) Antibody Mouse Monoclonal Anti-Human P120(MX124) Antibody Rabbit Monoclonal Anti-Human Androgen Receptor/AR(MXR023) Antibody Mouse Monoclonal Anti-Human HP(MX014) Antibody Rabbit Monoclonal Anti-Human Bcl-2(MXR073) Antibody Rabbit Monoclonal Anti-Human PTEN(MXR060) Antibody UltraSensitive TM SP(Mouse) IHC Kit(without chromogens) Mouse Monoclonal Anti-Human Desmin(MX046) Antibody Rabbit Monoclonal Anti-Human ERG(MXR004) Antibody Mouse Monoclonal Anti-Human Synaptophysin (MX038) Antibody Mouse Monoclonal Anti-Human Bcl-6(MX042) Antibody Mouse Monoclonal Anti-Human Human Growth Hormone(GH)(MX091) Antibody Mouse Monoclonal Anti-Human CD43(MX099) Antibody Mouse Monoclonal Anti-Human p53(MX008) Antibody Mouse Monoclonal Anti-Human P57(MX150) Antibody Rabbit Monoclonal Anti-Human Oligo-2(MXR048) Antibody Elivision Plus DAB Rabbit Monoclonal Anti-Human Cyclin D1(MXR056) Antibody Mouse Monoclonal Anti-Human FR?(MX129) Antibody Rabbit Monoclonal Anti-Human SSTR2(MXR041) Antibody Rabbit Monoclonal Anti-Human INI-1(MXR068) Antibody UltraSensitive TM SP(Goat) IHC Kit(without chromogens) MaxVision TM HRP(Rabbit) IHC Polymer 2 step Super HRP Detection Kit(For Autostaining System) Mouse Monoclonal Anti-Human BTLA(MX088) Antibody Rabbit Monoclonal Anti-Human Brachyury/Bry(MXR027) Antibody Mouse Monoclonal Anti-Human Inhibin Alpha(MX098) Antibody Mouse Monoclonal Anti-Human MUC2 (MX127) Antibody Mouse Monoclonal Anti-Human CA125(MX055) Antibody Mouse Monoclonal Anti-Human Topoisomerase II Alpha(TOPOII?)(MX108) Antibody Mouse Monoclonal Anti-Human SALL4(MX128) Antibody Mouse Monoclonal Anti-Human PD-1(MX033) Antibody Mouse Monoclonal Anti-Human CK20(MX059) Antibody Mouse Monoclonal Anti-Human ALK(MX064) Antibody Rabbit Monoclonal Anti-Human PMS2(MXR019) Antibody IHC Antigen Retrieval Solution(DNS) Mouse Monoclonal Anti-Human CD8(MX117) Antibody Mouse Monoclonal Anti-Human MGMT(MX114) Antibody Mouse Monoclonal Anti-Human ATRX(MX071) Antibody Mouse Monoclonal Anti-Human Bcl-2(MX022) Antibody Mouse Monoclonal Anti-Human Follicle-Stimulating Hormone (FSH)(MX116) Antibody Rabbit Monoclonal Anti-Human Pax-8(MXR013) Antibody Mouse Monoclonal Anti-Human MLH1(MX063) Antibody Mouse Monoclonal Anti-Human MUC-4(MX139) Antibody MaxVision TM 2 HRP(Mouse/Rabbit) IHC Polymer Mouse Monoclonal Anti-Human HBsAg(MX103) Antibody Mouse Monoclonal Anti-Human CD2(MX074) Antibody Mouse Monoclonal Anti-Human PSA(MX030) Antibody Mouse Monoclonal Anti-Human nm23(MX050) Antibody Mouse Monoclonal Anti-Human PSMA(MX095) Antibody Rabbit Monoclonal Anti-Human Nectin4(MXR067) Antibody Rabbit Monoclonal Anti-Human Arginase-1(MXR050) Antibody Ultra DAB Kit Rabbit Monoclonal Anti-Human P40(MXR010) Antibody Mouse Monoclonal Anti-Human P63(MX013) Antibody Rabbit Monoclonal Anti-Human CDX2(MXR024) Antibody Mouse Monoclonal Anti-Human Anti-Chromogranin A(MX018) Antibody Mouse Monoclonal Anti-Human Calretinin(MX027) Antibody Mouse Monoclonal Anti-Human Thyroglobulin(MX131) Antibody Mouse Monoclonal Anti-Human VISTA(MX086) Antibody Mouse Monoclonal Anti-Human Ki-67(MX006) Antibody Mouse Monoclonal Anti-Human MUC5AC(MX126) Antibody Mouse Monoclonal Anti-Human CD68(MX075) Antibody Mouse Monoclonal Anti-Human MNDA(MX122) Antibody Mouse Monoclonal Anti-Human Calponin(MX023) Antibody Rabbit Monoclonal Anti-Human B7H3(MXR045) Antibody Mouse Monoclonal Anti-Human FH(Fumarate hydratase)(MX146) Antibody PBS buffer Rabbit Monoclonal Anti-Human HER3(MXR053) Antibody Rabbit Monoclonal Anti-Human NUT(MXR076) Antibody UltraSensitive TM SP(Rabbit) IHC Kit(without chromogens) HRP and AP Polymer Cocktail Rabbit Monoclonal Anti-Human PD-L1(MXR006) Antibody Mouse Monoclonal Anti-Human DDIT3(MX144) Antibody IHC Antigen Retrieval Solution(EGTA) AEC Kit(20X) Rabbit Monoclonal Anti-Human B7H4(MXR054) Antibody Mouse Monoclonal Anti-Human CK8/18(MX004+MX035) Antibody Mouse Monoclonal Anti-Human Caldesmon(MX077) Antibody Elivision plus TM (Mouse/Rabbit) IHC Kit(without chromogens) Elivision Super DAB Rabbit Monoclonal Anti-Human PRAME(MXR072) Antibody Mouse Monoclonal Anti-Human Pgp(P-Glycoprotein)(MX079) Antibody Rabbit Monoclonal Anti-Human FR?(MXR066) Antibody UltraSensitive TM SP(Mouse/Rabbit) IHC Kit(without chromogens) MaxVision TM HRP(Mouse) IHC Polymer Mouse Monoclonal Anti-Human IDH-1(MX031) Antibody Mouse Monoclonal Anti-Human CD235a, Glycophorin A(MX142) Antibody Rabbit Monoclonal Anti-Human CD200(MXR044) Antibody IHC Antigen Retrieval Solution(Citric Acid) MaxVision TM 2 HRP(Mouse/Rabbit) IHC Kit Endogenous Biotin Blocking Kit IHC Antigen Retrieval Solution(Neutral) Mouse Monoclonal Anti-Human CD138(MX135) Antibody Mouse Monoclonal Anti-Human CYP11B1(MX136) Antibody MaxVision TM 3 HRP(Mouse/Rabbit) IHC Kit Biotin-labelled polymer(Mouse/Rabbit) Rabbit Monoclonal Anti-Human SSTR5(MXR042) Antibody Mouse Monoclonal Anti-Human CD15(MX143) Antibody Mouse Monoclonal Anti-Human LH(Luteinizing hormone)(MX148) Antibody

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KPA Slide Stainer, Automated Pathology Class 1 864.3800 2025-04-02
NJT Immunohistochemistry Reagents And Kits Hematology Class 1 864.1860 2023-12-14

Official Correspondent

Yanhua Zheng

US Agent Details

Joseph Yuen Email: a1792528160@gmail.com Phone: (510) 6518890

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Same Entity

Fuzhou Maixin Biotech Co., Ltd.
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030509363. Last updated year: 2026. Please use registration number 3030509363 when referencing this establishment in official correspondence.
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