Medical Device Division · registration 180033CancelledRoche Molecular Systems
Hong KongIVD Test Reagent/Kits, Molecular Assay, Nucleic Acid ProbeIVD Class DRoche Molecular Systems, Inc.
Official record identity
- MDACS listing number
- 180033
- Model name
- cobas TaqScreen MPX Test, v2.0 (05969492190), cobas TaqScreen MPX Control Kit, v2.0 (05965411190), cobas TaqScreen Wash Reagent (04404220190)
- Registration date
- February 20, 2018
- Source update date
- July 15, 2025
- Status
- Cancelled
Official value: Delisted
Classification
- Risk class
- IVD Class D
- Published category
- IVD Test Reagent/Kits, Molecular Assay, Nucleic Acid Probe
Official value: D
Published parties
- Registrant / registration holder
- Roche Diagnostics (Hong Kong) Limited
- Manufacturer
- Roche Molecular Systems, Inc.
Official description
IVD Test Reagent/Kits, Molecular Assay, Nucleic Acid Probe
Additional source fields
- AMD nomenclature code
- 19666
- Traditional Chinese local responsible person
- 羅氏診斷(香港)有限公司
- Local responsible person phone
- 24813387
- Published manufacturer address
- 1080 US Highway 202, South Branchburg, NJ 08876, USA
- Published remarks
- Delisted.
- Delist date
- 2023-03-03
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.