Medical Device Division · registration 220143ActiveAbbott
Hong KongIVD Test Reagent/Kits, Serology, Virus, Severe Acute Respiratory Syndrome Coronavirus 2IVD Class CAbbott Ireland Diagnostics Division
Official record identity
- MDACS listing number
- 220143
- Model name
- ARCHITECT SARS-CoV-2 IgG II Quant Calibrator Kit ((06S60-02)), ARCHITECT SARS-CoV-2 IgG II Quant Control Kit ((06S60-12)), ARCHITECT SARS-CoV-2 IgG II Quant Reagent Kit ((06S60-22)), ARCHITECT SARS-CoV-2 IgG II Quant Reagent Kit ((06S60-32))
- Registration date
- April 29, 2022
- Expiry date
- April 29, 2027
- Source update date
- July 19, 2023
- Status
- Active
Official value: Valid
Classification
- Risk class
- IVD Class C
- Published category
- IVD Test Reagent/Kits, Serology, Virus, Severe Acute Respiratory Syndrome Coronavirus 2
Official value: C
Published parties
- Registrant / registration holder
- Abbott Laboratories Limited
- Manufacturer
- Abbott Ireland Diagnostics Division
Official description
IVD Test Reagent/Kits, Serology, Virus, Severe Acute Respiratory Syndrome Coronavirus 2
Additional source fields
- AMD nomenclature code
- 41570
- Traditional Chinese local responsible person
- 美國雅培製藥有限公司
- Local responsible person phone
- 25668711
- Published manufacturer address
- Finisklin Business Park, Sligo, Ireland
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.