Medical Device Division · registration 241095Active

CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody (05278392001)

Name: CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody (05278392001) — Medical Device Division 241095
Creator: Ventana Medical Systems, Inc.
Keywords: CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody (05278392001), CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody (05278392001), 241095, IVD Panels, Human Genetics, Immunodeficiency, Primary Antibody Deficiency, Medical Device Division

Hong KongIVD Panels, Human Genetics, Immunodeficiency, Primary Antibody DeficiencyIVD Class CVentana Medical Systems, Inc.

Verified

Official record identity

MDACS listing number: 241095
Model name: CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody (05278392001)
Registration date: October 16, 2024
Expiry date: October 15, 2029
Source update date: December 17, 2024
Status: Active

Classification

Risk class: IVD Class C
Published category: IVD Panels, Human Genetics, Immunodeficiency, Primary Antibody Deficiency

Published parties

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

Official description

IVD Panels, Human Genetics, Immunodeficiency, Primary Antibody Deficiency

Additional source fields

AMD nomenclature code: 35750
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.