Medical Device Division · registration 241001ActiveBinaxNOW Legionella Urinary Antigen Card (852-012, 852-100), BinaxNOW Legionella Control Swab Pack (852-010)
Hong KongIVD Test Reagent/Kits, Immunoassay, Rapid Test, Bacteria, Legionella pneumophila, AntigenIVD Class CAbbott Diagnostics Scarborough, Inc.
Official record identity
- MDACS listing number
- 241001
- Model name
- BinaxNOW Legionella Urinary Antigen Card (852-012, 852-100), BinaxNOW Legionella Control Swab Pack (852-010)
- Registration date
- October 22, 2025
- Expiry date
- July 22, 2029
- Source update date
- November 14, 2025
- Status
- Active
Official value: Valid
Classification
- Risk class
- IVD Class C
- Published category
- IVD Test Reagent/Kits, Immunoassay, Rapid Test, Bacteria, Legionella pneumophila, Antigen
Official value: C
Published parties
- Registrant / registration holder
- Abbott Laboratories Limited
- Manufacturer
- Abbott Diagnostics Scarborough, Inc.
Official description
IVD Test Reagent/Kits, Immunoassay, Rapid Test, Bacteria, Legionella pneumophila, Antigen
Additional source fields
- AMD nomenclature code
- 42283
- Traditional Chinese local responsible person
- 美國雅培製藥有限公司
- Local responsible person phone
- 25668711
- Published manufacturer address
- 10 Southgate Road, Scarborough, ME 04074, United States of America
- 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.