Medical Device Division · registration 120326ActiveOrtho-Clinical Diagnostics
Hong KongIVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface AntigenIVD Class DOrtho-Clinical Diagnostics
Official record identity
- MDACS listing number
- 120326
- Model name
- VITROS Immunodiagnostic Products HBsAg Reagent Pack (8435307), HBsAg Calibrator (1421932)
- Registration date
- June 28, 2022
- Expiry date
- September 18, 2027
- Source update date
- July 21, 2023
- Status
- Active
Official value: Valid
Classification
- Risk class
- IVD Class D
- Published category
- IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antigen
Official value: D
Published parties
- Registrant / registration holder
- DCH Auriga (Hong Kong) Limited
- Manufacturer
- Ortho-Clinical Diagnostics
Official description
IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antigen
Additional source fields
- AMD nomenclature code
- 17360
- Traditional Chinese local responsible person
- 奧利佳(香港)有限公司
- Local responsible person phone
- 36192800
- Published manufacturer address
- Felindre Meadows, Pencoed, Bridgend CF35 5PZ, United Kingdom
- Revision number
- e
About this record
This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.