120108
IVD Test Reagent/Kits, Serology, Virus, Hepatitis C, Antibody
体外诊断 检测试剂/试剂盒、血清学、病毒、丙型肝炎、抗体
Ortho-Clinical Diagnostics·D·Hong Kong MDACS·Registered February 16, 2022
Device overview
- Risk class
- D
- Product code
- 17914
- State
- current
- Status
- N/A
- Product code detail
- 17914 IVD Test Reagent/Kits, Serology, Virus, Hepatitis C, 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 16, 2022
- Expiry date
- April 27, 2027
Product models
Vitros Immunodiagnostic Products Anti-HCV Reagent Pack (1318450), Vitros Immunodiagnostic Products Anti-HCV Calibrator (1940667), Vitros Immunodiagnostic Products Anti-HCV Controls (6800731)
体外免疫诊断产品 抗丙肝病毒试剂包 (1318450), 体外免疫诊断产品 抗丙肝病毒校准品 (1940667), 体外免疫诊断产品 抗丙肝对照 (6800731)
About this record
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Serology, Virus, Hepatitis C, 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, Hepatitis C, Antibody
產品資訊： 体外诊断 检测试剂/试剂盒、血清学、病毒、丙型肝炎、抗体