Medical Device Division · registration 120012ActiveOrtho-Clinical Diagnostics
Hong KongIVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface AntigenIVD Class DOrtho-Clinical Diagnostics
Official record identity
- MDACS listing number
- 120012
- Model name
- VITROS Immunodiagnostic Products HBsAg ES Reagent Pack (6802131), VITROS Immunodiagnostic Products HBsAg ES Calibrator (6802132), VITROS Immunodiagnostic Products HBsAg Controls (6800598)
- Registration date
- December 10, 2021
- Expiry date
- February 02, 2027
- Source update date
- August 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.