Medical Device Division · registration 220415ActiveAbbott
Hong KongIVD Test Reagent/Kits, Serology, Virus, Retrovirus, HIV-1/2IVD Class DAbbott GmbH
Official record identity
- MDACS listing number
- 220415
- Model name
- Alinity s HIV Ag/Ab Combo Reagent Kit (06P0155), Alinity s HIV Ag/Ab Combo Calibrator Kit (06P0102), Alinity s HIV Ag/Ab Combo Assay Control Kit (06P0110), Alinity s HIV Ag/Ab Combo Release Control Kit (06P0112)
- Registration date
- December 03, 2025
- Expiry date
- January 03, 2028
- Source update date
- July 30, 2026
- Status
- Active
Official value: Valid
Classification
- Risk class
- IVD Class D
- Published category
- IVD Test Reagent/Kits, Serology, Virus, Retrovirus, HIV-1/2
Official value: D
Published parties
- Registrant / registration holder
- Abbott Laboratories Limited
- Manufacturer
- Abbott GmbH
Official description
IVD Test Reagent/Kits, Serology, Virus, Retrovirus, HIV-1/2
Additional source fields
- AMD nomenclature code
- 19430
- Traditional Chinese local responsible person
- 美國雅培製藥有限公司
- Local responsible person phone
- 25668711
- Published manufacturer address
- Max-Planck-Ring 2, 65205 Wiesbaden, GERMANY
- Revision number
- a
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.