Medical Device Division · registration 241100Active

PreciControl HCV Duo (08335923190 ), Elecsys HCV Duo (08110697190)

Name: PreciControl HCV Duo (08335923190 ), Elecsys HCV Duo (08110697190) — Medical Device Division 241100
Creator: Roche Diagnostics GmbH
Keywords: PreciControl HCV Duo (08335923190 ), Elecsys HCV Duo (08110697190), PreciControl HCV Duo (08335923190 ), Elecsys HCV Duo (08110697190), 241100, IVD Test Reagent/Kits, Serology, Virus, Hepatitis C, Medical Device Division

Hong KongIVD Test Reagent/Kits, Serology, Virus, Hepatitis CIVD Class DRoche Diagnostics GmbH

Verified

Official record identity

MDACS listing number: 241100
Model name: PreciControl HCV Duo (08335923190 ), Elecsys HCV Duo (08110697190)
Registration date: October 16, 2024
Expiry date: October 15, 2029
Source update date: February 10, 2025
Status: Active

Classification

Risk class: IVD Class D
Published category: IVD Test Reagent/Kits, Serology, Virus, Hepatitis C

Published parties

Registrant / registration holder: Roche Diagnostics (Hong Kong) Limited
Manufacturer: Roche Diagnostics GmbH

Official description

IVD Test Reagent/Kits, Serology, Virus, Hepatitis C

Additional source fields

AMD nomenclature code: 19410
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.