220359
IVD Test Reagent/Kits, Immunoassay, Rapid Test, Virus Severe Acute Respiratory Syndrome Coronavirus 2, Antigen
体外诊断 检测试剂/试剂盒、免疫测定、快速检测、病毒严重急性呼吸综合征冠状病毒2、抗原
InTec PRODUCTS, INC.·C·Hong Kong MDACS·Registered November 03, 2022
Device overview
- Risk class
- C
- Product code
- 41964
- State
- N/A
- Status
- N/A
- Product code detail
- 41964 IVD Test Reagent/Kits, Immunoassay, Rapid Test, Virus Severe Acute Respiratory Syndrome Coronavirus 2, Antigen
Manufacturer (製造商)
- Name
- InTec PRODUCTS, INC.英科新创（厦门）科技股份有限公司
- Address
- 332 Xinguang Road, Xinyang Industrial Area, Haicang, 361022 Xiamen, Fujian, PEOPLE'S REPUBLIC OF CHINA新阳工业区新光路332号, 海沧, 361022厦门, 福建省, 中华人民共和国
Authorised representative (AR)
- Phone
- 39552662
Regulatory timeline
- Registration date
- November 03, 2022
- Expiry date
- November 03, 2027
Product models
Rapid SARS-CoV-2 Antigen Test (ITP16010-TC1, ITP16010-TC5, ITP16010-TC25)
SARS-CoV-2 快速抗原检测(ITP16010-TC1、ITP16010-TC5、ITP16010-TC25)
About this record
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Rapid Test, Virus Severe Acute Respiratory Syndrome Coronavirus 2, Antigen. Review device classification, authorised representative (AR) details, manufacturer contacts, product codes, and regulatory milestones. Pure Global AI delivers bilingual transparency for medical device registrations across Asia.
Product Info: IVD Test Reagent/Kits, Immunoassay, Rapid Test, Virus Severe Acute Respiratory Syndrome Coronavirus 2, Antigen
產品資訊： 体外诊断 检测试剂/试剂盒、免疫测定、快速检测、病毒严重急性呼吸综合征冠状病毒2、抗原