Medical Device Division · registration 230424ActiveRemel
Hong KongIVD Test Reagent/Kits, Serology, Fungi/Yeast, Cryptococcus neoformans, AntigenIVD Class CRemel, Inc.
Official record identity
- MDACS listing number
- 230424
- Model name
- Cryptococcus Antigen Latex Test (R30851501)
- Registration date
- November 15, 2023
- Expiry date
- November 15, 2028
- Source update date
- October 02, 2024
- Status
- Active
Official value: Valid
Classification
- Risk class
- IVD Class C
- Published category
- IVD Test Reagent/Kits, Serology, Fungi/Yeast, Cryptococcus neoformans, Antigen
Official value: C
Published parties
- Registrant / registration holder
- Thermo Fisher Scientific (Hong Kong) Limited
- Manufacturer
- Remel, Inc.
Official description
IVD Test Reagent/Kits, Serology, Fungi/Yeast, Cryptococcus neoformans, Antigen
Additional source fields
- AMD nomenclature code
- 19447
- 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
- 12076 Santa Fe Trail Drive, Lenexa, Kansas, 66215, USA
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.