Medical Device Division · registration 220417ActiveAbbott
Hong KongIVD Test Reagent/Kits, Serology, Virus, Retrovirus, Human T-Cell Lymphotropic Virus-I/II, AntibodyIVD Class DAbbott GmbH
Official record identity
- MDACS listing number
- 220417
- Model name
- Alinity s HTLV I/II Reagent Kit (06P0755), Alinity s HTLV I/II Calibrator Kit (06P0702), Alinity s HTLV I/II Assay Control Kit (06P0710), Alinity s HTLV I/II Release Control Kit (06P0712)
- 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, Human T-Cell Lymphotropic Virus-I/II, Antibody
Official value: D
Published parties
- Registrant / registration holder
- Abbott Laboratories Limited
- Manufacturer
- Abbott GmbH
Official description
IVD Test Reagent/Kits, Serology, Virus, Retrovirus, Human T-Cell Lymphotropic Virus-I/II, Antibody
Additional source fields
- AMD nomenclature code
- 19073
- 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.