241095
C
current
IVD Panels, Human Genetics, Immunodeficiency, Primary Antibody Deficiencyไฝๅค่ฏๆญ้ขๆฟ, ไบบ็ฑป้ไผ ๅญฆ, ๅ ็ซ็ผบ้ท, ๅๅๆงๆไฝ็ผบไน็
This profile provides complete Hong Kong MDACS registration information for IVD Panels, Human Genetics, Immunodeficiency, Primary Antibody Deficiency. Review device classification, authorised representative (AR) details, manufacturer contacts, product codes, and regulatory milestones. Pure Global AI delivers bilingual transparency for medical device registrations across Asia.
Product Info: IVD Panels, Human Genetics, Immunodeficiency, Primary Antibody Deficiency
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ้ขๆฟ, ไบบ็ฑป้ไผ ๅญฆ, ๅ ็ซ็ผบ้ท, ๅๅๆงๆไฝ็ผบไน็
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
C
Product Code
35750
Product Code Detail
35750 IVD Panels, Human Genetics, Immunodeficiency, Primary Antibody Deficiency
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Ventana Medical Systems, Inc.
Ventana Medical Systems,Inc.
United States
็พๅฝ
1910 East Innovation Park Drive, Tucson AZ 85755, USA
1910ไธๅๆฐๅญๅคง้,ๅพๆฃฎAZ 85755,็พๅฝ
Authorised Representative (AR)
Regulatory Timeline
Registration Date
October 16, 2024
Expiry Date
October 15, 2029
Product Models
CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody (05278392001)
CONFIRM ๆๅญๆฟ็ด ๅไฝ (PR) (1E2) ๅ
ๅๅ
้ไธๆ (05278392001)