Medical Device Division · registration 241110Active

IGA-2 (03507343190, 05219205190, 08057885190)

Name: IGA-2 (03507343190, 05219205190, 08057885190) — Medical Device Division 241110
Creator: Roche Diagnostics GmbH
Keywords: IGA-2 (03507343190, 05219205190, 08057885190), IGA-2 (03507343190, 05219205190, 08057885190), 241110, IVD Test Reagent/Kits, Immunoassay, Protein, Immunoglobulin A, Medical Device Division

Hong KongIVD Test Reagent/Kits, Immunoassay, Protein, Immunoglobulin AIVD Class BRoche Diagnostics GmbH

Verified

Official record identity

MDACS listing number: 241110
Model name: IGA-2 (03507343190, 05219205190, 08057885190)
Registration date: October 16, 2024
Expiry date: October 15, 2029
Source update date: March 28, 2025
Status: Active

Classification

Risk class: IVD Class B
Published category: IVD Test Reagent/Kits, Immunoassay, Protein, Immunoglobulin A

Published parties

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

Official description

IVD Test Reagent/Kits, Immunoassay, Protein, Immunoglobulin A

Additional source fields

AMD nomenclature code: 17369
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.