Medical Device Division · registration 240421ActiveElecsys Androstenedione (07679840190, 07679831190), CalSet Androstenedione (07679866190)
Hong KongIVD Test Reagent/Kits, Immunoassay, Fertility Hormone, AndrostenedioneIVD Class BRoche Diagnostics GmbH
Official record identity
- MDACS listing number
- 240421
- Model name
- Elecsys Androstenedione (07679840190, 07679831190), CalSet Androstenedione (07679866190)
- Registration date
- September 24, 2024
- Expiry date
- September 23, 2029
- Source update date
- March 28, 2025
- Status
- Active
Official value: Valid
Classification
- Risk class
- IVD Class B
- Published category
- IVD Test Reagent/Kits, Immunoassay, Fertility Hormone, Androstenedione
Official value: B
Published parties
- Registrant / registration holder
- Roche Diagnostics (Hong Kong) Limited
- Manufacturer
- Roche Diagnostics GmbH
Official description
IVD Test Reagent/Kits, Immunoassay, Fertility Hormone, Androstenedione
Additional source fields
- AMD nomenclature code
- 19867
- Traditional Chinese local responsible person
- 羅氏診斷(香港)有限公司
- Local responsible person phone
- 24813387
- Published manufacturer address
- Sandhofer Strasse 116, 68305 Mannheim, Germany
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.