Medical Device Division · registration 110027ExpiredOrtho-Clinical Diagnostics
Hong KongIVD Test Reagent/Kits, Serology, Virus, Retrovirus, HIV-1/2, AntibodyIVD Class DOrtho-Clinical Diagnostics
Official record identity
- MDACS listing number
- 110027
- Model name
- Vitros Immunodiagnostic Products Anti-HIV 1+2 (1241850, 1700863, 6800586)
- Registration date
- February 03, 2021
- Expiry date
- April 08, 2026
- Source update date
- July 12, 2023
- Status
- Expired
Classification
- Risk class
- IVD Class D
- Published category
- IVD Test Reagent/Kits, Serology, Virus, Retrovirus, HIV-1/2, Antibody
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, Retrovirus, HIV-1/2, Antibody
Additional source fields
- AMD nomenclature code
- 19070
- 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
- Published remarks
- Expired.
- Revision number
- d
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.