200268
D
current
IVD Test Reagent/Kits, Serology, Virus, Retrovirus, HIV-1/2, Antigenไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใ่กๆธ ๅญฆใ็ ๆฏใ้่ฝฌๅฝ็ ๆฏใHIV-1/2ใๆๅ
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Serology, Virus, Retrovirus, HIV-1/2, Antigen. 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 Test Reagent/Kits, Serology, Virus, Retrovirus, HIV-1/2, Antigen
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใ่กๆธ ๅญฆใ็ ๆฏใ้่ฝฌๅฝ็ ๆฏใHIV-1/2ใๆๅ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
D
Product Code
19069
Product Code Detail
19069 IVD Test Reagent/Kits, Serology, Virus, Retrovirus, HIV-1/2, Antigen
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
BIO-RAD
Bio-Rad
3 Boulevard Raymond Poincarรฉ, 92430 MARNES LA COQUETTE FRANCE
3 ๅคง้้ท่ๅพทๅบๅ ่ฑ, 92430 ้ฉฌๆฉๆฏๆ็งๆๅจ่้ฆๅ
ฌๆฅๅฎๆฏ
Authorised Representative (AR)
2789 3300 / 63365950
Regulatory Timeline
Registration Date
July 22, 2020
Expiry Date
July 22, 2025
Product Models
Geenius HIV 1/2 Confirmatory Assay (72460), Geenius HIV 1/2 Confirmatory Controls (72329)
Geenius HIV 1/2 ็กฎ่ฎคๆงๆฃๆต (72460),Geenius HIV 1/2 ็กฎ่ฎคๆงๅฏน็
ง (72329)