{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-10-26", "results": { "skip": 0, "limit": 1, "total": 3 } }, "results": [ { "proprietary_name": [ "EWSR1/FLI1 Dual Color Dual Fusion probe", "PLAG1 Dual Color Break Apart Probe", "NCOA2 Dual Color Break Apart Probe", "MYB Dual Color Break Apart Probe", "WT1 Dual Color Break Apart Probe", "TERC/CSP3 Dual Color Probe", "ALK/CSP2 Dual Color Probe", "2p Orange Probe", "IRF4 Dual Color Break Apart Probe", "RELA Dual Color Break Apart Probe", "ETV6/NTRK3 Dual Color Dual Fusion probe", "SMARCB1/EWSR1 Dual Color Probe", "CREB1/EWSR1 Dual Color Dual Fusion probe", "FOSB Dual Color Break Apart Probe", "i(17q) Dual Color Probe", "BRAF Dual Color Break Apart Probe", "D13S319 Orange Probe", "COL1A1/PDGFB Dual Color Dual Fusion probe", "Twist/CSP7 Dual Color Probe", "hWAPL/CSP10 Dual Color Probe", "Wash buffer(For Tissue Section)", "PPAR? Dual Color Break Apart Probe", "ABL2 Dual Color Break Apart Probe", "MALAT1 Dual Color Break Apart Probe", "TLX1 Dual Color Break Apart Probe", "EP400 Dual Color Break Apart Probe", "TFEB Dual Color Break Apart Probe", "FOXR2 Dual Color Break Apart Probe", "PAX3 Dual Color Break Apart Probe", "CDK6/CSP7 Dual Color Probe", "MLAA-34/13q34 Dual Color Probe", "CIC Dual Color Break Apart Probe", "JAZF1 Dual Color Break Apart Probe", "RAD21/CSP8 Dual Color Probe", "NONO/TFE3 Dual Color Dual Fusion probe", "PD-L2/CSP9 Dual Color Probe", "DDIT3/CSP12 Dual Color Probe", "MLLT4/CSP6 Dual Color Probe", "CSP7 Green Probe", "ZNF384 Dual Color Break Apart Probe", "PDGFB Dual Color Break Apart Probe", "CRTC1 Dual Color Break Apart Probe", "NCOA3 Dual Color Break Apart Probe", "STAT6/CSP12 Dual Color Probe", "NUT Dual Color Break Apart Probe", "Buffer solution", "NR4A3 Dual Color Break Apart Probe", "TP63 Dual Color Break Apart Probe", "DAPI Staining Solution", "Pepsin Solution(For tissue section)", "PTPRZ1/C-MET Fusion probe", "CSF1 Dual Color Break Apart Probe", "ERG Dual Color Break Apart Probe", "PD-L1 Dual Color Break Apart Probe", "ESR1/CSP6 Dual Color Probe", "1q Orange Probe", "11q23.3/11q24.3 Dual Color Probe", "PRDM10 Dual Color Break Apart Probe", "SOX2/CSP3 Dual Color Probe", "MYC Dual Color Break Apart Probe", "5q33.3 Dual Color Probe", "MN1 Dual Color Break Apart Probe", "NFIB Dual Color Break Apart Probe", "P16(CDKN2A)/CSP9 Dual Color Probe", "Wash buffer(For Cell Section)", "YWHAE Dual Color Break Apart Probe", "FOXO1 Dual Color Break Apart Probe", "CCND2 Dual Color Break Apart Probe", "TRA/TRD Dual Color Break Apart Probe", "BCL6 Dual Color Break Apart Probe", "USP6 Dual Color Break Apart Probe", "C19MC/19p13 Dual Color Probe", "EBER(Epstein-Barr Virus RNA) Probe kit", "CSP17 Green Probe", "GLI1 Dual Color Break Apart Probe", "HMGA2 Dual Color Break Apart Probe", "TNFAIP3/CSP6 Dual Color Probe", "RB1/1q21 Dual Color Probe", "CTNNB1/CSP3 Dual Color Probe", "BCOR Dual Color Break Apart Probe", "11q22.2 Orange Probe", "CSF1R Dual Color Break Apart Probe", "CAMTA1 Dual Color Break Apart Probe", "C11ORF95 Dual Color Break Apart Probe", "PRKACA Dual Color Break Apart Probe", "ETV4 Dual Color Break Apart Probe", "FGFR2 Dual Color Break Apart Probe", "MGEA5 Dual Color Break Apart Probe", "D11S1037/CSP11 Dual Color Probe", "NTRK3 Dual Color Break Apart Probe", "KMT2A/CSP11 Dual Color Probe", "CSP8 Green Probe", "D13S25 Orange Probe", "FRS2/CSP12 Dual Color Probe", "19p13.3/19q13 Dual Color Probe", "CDH1/CSP16 Dual Color Probe", "ABL1 Dual Color Break Apart Probe", "MEF2D Dual Color Break Apart Probe", "1q21 Orange Probe", "C11ORF95/RELA Fusion probe", "Fixation Solution", "Sample Release Agent", "SRD/CSP1 Dual Color Probe", "NUP98 Dual Color Break Apart Probe", "EPOR Dual Color Break Apart Probe", "Pepsin Solution(For cell sample)", "CSP11 Green Probe", "TOP2A/CSP17 Dual Color Probe", "RB1/ATM Dual Color Probe", "BEND2 Dual Color Break Apart Probe", "MYC/CSP8 Dual Color Probe", "MAML2 Dual Color Break Apart Probe", "Epstein-Barr Virus (EBER) Probe(in situ hybridization)", "CHD1/TERT Dual Color Probe", "NTRK2 Dual Color Break Apart Probe", "EWSR1/ATF1 Dual Color Dual Fusion probe", "20q11 Green Probe", "PRCC/TFE3 Dual Color Dual Fusion probe", "PAX5/IGH Dual Color Dual Fusion probe", "FOS Dual Color Break Apart Probe", "BCL2 Dual Color Break Apart Probe" ], "establishment_type": [ "Manufacture Medical Device" ], "registration": { "registration_number": "3030509363", "fei_number": "3030509363", "status_code": "1", "initial_importer_flag": "N", "reg_expiry_date_year": "2026", "name": "FUZHOU MAIXIN BIOTECH CO., LTD.", "address_line_1": "No. 98, Chaipai Road, Shangjie Town, Minhou County", "address_line_2": "", "city": "Fuzhou City Fujian", "state_code": "", "iso_country_code": "CN", "zip_code": "", "postal_code": "350108", "us_agent": { "name": "Joseph Yuen", "business_name": "", "bus_phone_area_code": "510", "bus_phone_num": "6518890", "bus_phone_extn": "", "fax_area_code": "", "fax_num": "", "email_address": "a1792528160@gmail.com", "address_line_1": "1870 Milmont Drive,Milpitas,CA 95035,USA", "address_line_2": "", "city": "Milpitas", "state_code": "CA", "iso_country_code": "US", "zip_code": "95035", "postal_code": "" }, "owner_operator": { "firm_name": "Fuzhou Maixin Biotech Co., Ltd.", "owner_operator_number": "10089536", "official_correspondent": { "first_name": "Lilin", "middle_initial": "", "last_name": "Wang", "subaccount_company_name": "", "phone_number": "86-591-83732741-x" }, "contact_address": { "address_1": "No. 98, Chaipai Road, Shangjie Town, Minhou County", "address_2": "", "city": "Fuzhou City", "state_code": "CN-FJ", "state_province": "Fujian", "iso_country_code": "CN", "postal_code": "350108" } } }, "pma_number": "", "k_number": "", "products": [ { "product_code": "PPM", "created_date": "2025-03-14", "owner_operator_number": "10089536", "exempt": "", "openfda": { "device_name": "General Purpose Reagent", "medical_specialty_description": "Pathology", "regulation_number": "864.4010", "device_class": "1" } } ] } ] }