120326
IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antigen
体外诊断 检测试剂/试剂盒、血清学、病毒、乙型肝炎、表面抗原
Ortho-Clinical Diagnostics·D·Hong Kong MDACS·Registered June 28, 2022
Device overview
- Risk class
- D
- Product code
- 17360
- State
- current
- Status
- N/A
- Product code detail
- 17360 IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antigen
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
- June 28, 2022
- Expiry date
- September 18, 2027
Product models
VITROS Immunodiagnostic Products HBsAg Reagent Pack (8435307), HBsAg Calibrator (1421932)
体外免疫诊断产品 HBsAg 试剂包 (8435307), HBsAg 校准品 (1421932)
About this record
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface 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, Serology, Virus, Hepatitis B, Surface Antigen
產品資訊： 体外诊断 检测试剂/试剂盒、血清学、病毒、乙型肝炎、表面抗原