Medical Device Division · registration 241120ActiveRoche Diagnostics GmbH
Hong KongIVD Test Reagent/Kits, Serology, Virus, Severe Acute Respiratory Syndrome Coronavirus 2, AntibodyIVD Class CRoche Diagnostics GmbH
Official record identity
- MDACS listing number
- 241120
- Model name
- Elecsys Anti-SARS-CoV-2 (09203079190, 09203095190), PreciControl Anti-SARS-CoV-2 (09216928190)
- Registration date
- October 16, 2024
- Expiry date
- October 15, 2029
- Source update date
- December 13, 2024
- Status
- Active
Official value: Valid
Classification
- Risk class
- IVD Class C
- Published category
- IVD Test Reagent/Kits, Serology, Virus, Severe Acute Respiratory Syndrome Coronavirus 2, Antibody
Official value: C
Published parties
- Registrant / registration holder
- Roche Diagnostics (Hong Kong) Limited
- Manufacturer
- Roche Diagnostics GmbH
Official description
IVD Test Reagent/Kits, Serology, Virus, Severe Acute Respiratory Syndrome Coronavirus 2, Antibody
Additional source fields
- AMD nomenclature code
- 41674
- 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.