Medical Device Division · registration 230106ActiveOxoid
Hong KongIVD Test Reagent/Kits, Serology, Bacteria, Streptococcus SpeciesIVD Class COxoid Limited
Official record identity
- MDACS listing number
- 230106
- Model name
- PathoDxtra Disposable Cards (DR0720G), PathoDxtra Extraction Reagents (DR0709M), PathoDxtra Positive Control (DR0707G), PathoDxtra Strep Group A Latex (DR0701G), PathoDxtra Strep Group B Latex (DR0702G), PathoDxtra Strep Group C Latex (DR0703G), PathoDxtra Strep Group D Latex (DR0704G), PathoDxtra Strep Group F Latex (DR0705G), PathoDxtra Strep Group G Latex (DR0706G), PathoDxtra Strep Grouping Kit (DR0700M), PathoDxtra Strep Grouping Reagent Set (DR0710M)
- Registration date
- June 25, 2026
- Expiry date
- March 22, 2028
- Status
- Active
Official value: Valid
Classification
- Risk class
- IVD Class C
- Published category
- IVD Test Reagent/Kits, Serology, Bacteria, Streptococcus Species
Official value: C
Published parties
- Registrant / registration holder
- Thermo Fisher Scientific (Hong Kong) Limited
- Manufacturer
- Oxoid Limited
Official description
IVD Test Reagent/Kits, Serology, Bacteria, Streptococcus Species
Additional source fields
- AMD nomenclature code
- 19049
- 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.