Medical Device Division · registration 241078Active

Alu Positive Control Probe (05278694001)

Name: Alu Positive Control Probe (05278694001) — Medical Device Division 241078
Creator: Ventana Medical Systems, Inc.
Keywords: Alu Positive Control Probe (05278694001), Alu Positive Control Probe (05278694001), 241078, IVD Test Reagent/Kits, Immunocytochemistry/Immunohistochemistry, Stain, Medical Device Division

Hong KongIVD Test Reagent/Kits, Immunocytochemistry/Immunohistochemistry, StainIVD Class BVentana Medical Systems, Inc.

Verified

Official record identity

MDACS listing number: 241078
Model name: Alu Positive Control Probe (05278694001)
Registration date: October 16, 2024
Expiry date: October 15, 2029
Source update date: February 17, 2025
Status: Active

Classification

Risk class: IVD Class B
Published category: IVD Test Reagent/Kits, Immunocytochemistry/Immunohistochemistry, Stain

Published parties

Registrant / registration holder: Roche Diagnostics (Hong Kong) Limited
Manufacturer: Ventana Medical Systems, Inc.

Official description

IVD Test Reagent/Kits, Immunocytochemistry/Immunohistochemistry, Stain

Additional source fields

AMD nomenclature code: 32974
Traditional Chinese local responsible person: 羅氏診斷(香港)有限公司
Local responsible person phone: 24813387
Published manufacturer address: 1910 East Innovation Park Drive, Tucson AZ 85755, USA

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.