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Registrant profile

Goldsite Diagnostics Inc.

深圳市国赛生物技术有限公司
Guangdong·China NMPA·186 registered devices
186
Total devices
2
Device classes
2019
Earliest approval
2025
Latest approval
Company overview
Total devices
186
Province/Region
Guangdong
广东
Address
103C, 503C, 504D Science and Technology Building, Merchants Street, Nanshan District, Shenzhen; No. 3A, No. 4A, Auxiliary Building of Science and Technology Building
深圳市南山区招商街道科技大厦103C、503C、504D；科技大厦辅楼3A号、4A号
Registration timeline
Earliest approval
Jan 24, 2019
Latest approval
Jan 21, 2025
Device class distribution
Breakdown of 186 devices by regulatory classification
Class II
179
96.2% of total
Class III
7
3.8% of total
Registered devices (10 most recent shown)
Click on any device for detailed registration information
Product nameClassRegistration numberApproval dateExpiry dateDetail
Fully automatic specific protein biochemical analyzer
全自动特定蛋白生化分析仪
Class II粤械注准20252220093Jan 21, 2025Jan 20, 2030View
Full-scale C-reactive protein (ultra-sensitive CRP + conventional CRP) assay kit (rate scatter turbidimetry)
全量程C反应蛋白(超敏CRP+常规CRP)测定试剂盒(速率散射比浊法)
Class II粤械注准20242401073Aug 12, 2024Aug 11, 2029View
Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method)
新型冠状病毒（2019-nCoV）抗原检测试剂盒（胶体金法）
Class III国械注准20243401443Aug 09, 2024Aug 08, 2029View
糖类抗原50（CA50）测定试剂盒（直接化学发光法）
Class II粤械注准20242400599Apr 25, 2024Apr 24, 2029View
Cancer Antigen 72-4 (CA72-4) Assay Kit (Direct Chemiluminescence Method)
癌抗原72-4（CA72-4）测定试剂盒（直接化学发光法）
Class II粤械注准20242400520Apr 15, 2024Apr 14, 2029View
Squamous Epithelial Cell Carcinoma (SCC) Antigen Assay Kit (Direct Chemiluminescence Method)
鳞状上皮细胞癌（SCC）抗原测定试剂盒（直接化学发光法）
Class II粤械注准20242400474Mar 29, 2024Mar 28, 2029View
Human Epididymal Protein 4 (HE4) Assay Kit (Direct Chemiluminescence Method)
人附睾蛋白4（HE4）测定试剂盒（直接化学发光法）
Class II粤械注准20242400370Mar 12, 2024Mar 11, 2029View
Carbohydrate Antigen 242 (CA242) Assay Kit (Direct Chemiluminescence Method)
糖类抗原242(CA242)测定试剂盒（直接化学发光法）
Class II粤械注准20242400287Feb 19, 2024Feb 18, 2029View
Total Prostate-Specific Antigen (TPSA) Assay Kit (Direct Chemiluminescence Method)
总前列腺特异性抗原（TPSA）测定试剂盒（直接化学发光法）
Class III国械注准20243400262Feb 02, 2024Feb 01, 2029View
Free Prostate-Specific Antigen (FPSA) Assay Kit (Direct Chemiluminescence Method)
游离前列腺特异性抗原（FPSA）测定试剂盒（直接化学发光法）
Class III国械注准20243400180Jan 26, 2024Jan 25, 2029View
About this profile

Complete regulatory portfolio for Goldsite Diagnostics Inc. in China's medical device market. This registrant has 186 medical devices registered with China NMPA, with registrations dating from Jan 24, 2019 to Jan 21, 2025.

Browse the complete device portfolio including device classifications, registration numbers, approval dates, and technical specifications. Pure Global AI provides free access to comprehensive China NMPA registration data, helping global MedTech companies analyze market presence and regulatory compliance for Chinese medical device manufacturers.