Medical Device Division · registration 220016CancelledSD Biosensor
Hong KongIVD Test Reagent/Kits, Serology, Virus, Severe Acute Respiratory Syndrome Coronavirus 2, AntigenIVD Class CSD Biosensor, Inc.
Official record identity
- MDACS listing number
- 220016
- Model name
- SARS-CoV-2 Antigen Self Test Nasal (9901-NCOV-06G)
- Registration date
- January 20, 2022
- Source update date
- July 15, 2025
- Status
- Cancelled
Official value: Delisted
Classification
- Risk class
- IVD Class C
- Published category
- IVD Test Reagent/Kits, Serology, Virus, Severe Acute Respiratory Syndrome Coronavirus 2, Antigen
Official value: C
Published parties
- Registrant / registration holder
- Roche Diagnostics (Hong Kong) Limited
- Manufacturer
- SD Biosensor, Inc.
Official description
IVD Test Reagent/Kits, Serology, Virus, Severe Acute Respiratory Syndrome Coronavirus 2, Antigen
Additional source fields
- AMD nomenclature code
- 41618
- Traditional Chinese local responsible person
- 羅氏診斷(香港)有限公司
- Local responsible person phone
- 24813387
- Published manufacturer address
- C-4th&Sth, 16, Deogyeong-daero, 1556beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do 16690, REPUBLIC OF KOREA
- Published remarks
- Delisted.
- Delist date
- 2024-07-08
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.