Medical Device Division · registration 220231ActiveOxoid
Hong KongIVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Legionella SpeciesIVD Class BOxoid Limited
Official record identity
- MDACS listing number
- 220231
- Model name
- Legionella Latex Test (DR0800M), Legionella pneumo group 1 (DR0801M), Legionella pneumo groups 2-14 (DR0802M), Legionella species test kit (DR0803M)
- Registration date
- June 25, 2026
- Expiry date
- August 18, 2027
- Status
- Active
Official value: Valid
Classification
- Risk class
- IVD Class B
- Published category
- IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Legionella Species
Official value: B
Published parties
- Registrant / registration holder
- Thermo Fisher Scientific (Hong Kong) Limited
- Manufacturer
- Oxoid Limited
Official description
IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Legionella Species
Additional source fields
- AMD nomenclature code
- 21740
- Traditional Chinese local responsible person
- 賽默飛世爾科技(香港)有限公司
- Local responsible person phone
- 31077600
- Published manufacturer address
- Wade Road, Basingstoke, Hampshire, RG24 8PW, United Kingdom
- 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.