110027
IVD Test Reagent/Kits, Serology, Virus, Retrovirus, HIV-1/2, Antibody
体外诊断 检测试剂/试剂盒、血清学、病毒、逆转录病毒、HIV-1/2、抗体
Ortho-Clinical Diagnostics·D·Hong Kong MDACS·Registered February 03, 2021
Device overview
- Risk class
- D
- Product code
- 19070
- State
- current
- Status
- N/A
- Product code detail
- 19070 IVD Test Reagent/Kits, Serology, Virus, Retrovirus, HIV-1/2, Antibody
Manufacturer (製造商)
- Name
- Ortho-Clinical DiagnosticsOrtho-Clinical Diagnostics, Inc.
- Country
- United Kingdom英国
- Address
- Felindre Meadows, Pencoed, Bridgend CF35 5PZ, United KingdomFelindre Meadows, Pencoed, Bridgend CF35 5PZ, 英国
Authorised representative (AR)
- Name
- DCH Auriga (Hong Kong) Limited奥利佳(香港)有限公司
- Phone
- 36192800
Regulatory timeline
- Registration date
- February 03, 2021
- Expiry date
- April 08, 2026
Product models
Vitros Immunodiagnostic Products Anti-HIV 1+2 (1241850, 1700863, 6800586)
体外免疫诊断产品抗HIV1+2(1241850、1700863、6800586)
About this record
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Serology, Virus, Retrovirus, HIV-1/2, Antibody. 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, Serology, Virus, Retrovirus, HIV-1/2, Antibody
產品資訊： 体外诊断 检测试剂/试剂盒、血清学、病毒、逆转录病毒、HIV-1/2、抗体