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Legacy registrant archive

Goldsite Diagnostics Inc.

深圳市国赛生物技术有限公司
GuangdongChina NMPA186 archived records
Static archiveNMPA · legacy registration snapshot
186
Archived records
2
Device classes
2019
Earliest approval
2025
Latest approval
Company overview
Archived records
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
Regulatory footprint
Search Goldsite Diagnostics Inc. across other regulatory registries
ThailandEuropean UnionColombiaSouth KoreaCanadaEcuador
Device class distribution
Breakdown of 186 devices by regulatory classification
Class II17996.2% of total
Class III73.8% of total
Archived records (10 most recent shown)
Click on any device for detailed registration information
Fully automatic specific protein biochemical analyzer
全自动特定蛋白生化分析仪
Jan 21, 2025
Registration number
粤械注准20252220093
Class
Class II
Expiry date
Jan 20, 2030
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)
Aug 12, 2024
Registration number
粤械注准20242401073
Class
Class II
Expiry date
Aug 11, 2029
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）
Aug 09, 2024
Registration number
国械注准20243401443
Class
Class III
Expiry date
Aug 08, 2029
糖类抗原50（CA50）测定试剂盒（直接化学发光法）
Apr 25, 2024
Registration number
粤械注准20242400599
Class
Class II
Expiry date
Apr 24, 2029
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）
Apr 15, 2024
Registration number
粤械注准20242400520
Class
Class II
Expiry date
Apr 14, 2029
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）
Mar 29, 2024
Registration number
粤械注准20242400474
Class
Class II
Expiry date
Mar 28, 2029
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）
Mar 12, 2024
Registration number
粤械注准20242400370
Class
Class II
Expiry date
Mar 11, 2029
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）
Feb 19, 2024
Registration number
粤械注准20242400287
Class
Class II
Expiry date
Feb 18, 2029
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）
Feb 02, 2024
Registration number
国械注准20243400262
Class
Class III
Expiry date
Feb 01, 2029
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）
Jan 26, 2024
Registration number
国械注准20243400180
Class
Class III
Expiry date
Jan 25, 2029
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About this profile

This static archive contains 186 records under the historical name Goldsite Diagnostics Inc.. It does not establish the company's complete current portfolio or current authorization status.

Historical English translations and official Chinese names can differ. These archived names are not automatically equated with a holder in the current domestic-registration listing.