200496
D
current
IVD Test Reagent/Kits, Serology, Virus, Retrovirus, HIV-1, Antigenไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใ่กๆธ ๅญฆใ็ ๆฏใ้่ฝฌๅฝ็ ๆฏใHIV-1ใๆๅ
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Serology, Virus, Retrovirus, HIV-1, 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, Antigen
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใ่กๆธ ๅญฆใ็ ๆฏใ้่ฝฌๅฝ็ ๆฏใHIV-1ใๆๅ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
D
Product Code
19066
Product Code Detail
19066 IVD Test Reagent/Kits, Serology, Virus, Retrovirus, HIV-1, 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 ้ฉฌๆฉๆฏๆ็งๅจ็น, ่้ฆๅ
ฌๆฅ ๅฎๆฏ
Authorised Representative (AR)
2789 3300 / 63365950
Regulatory Timeline
Registration Date
December 08, 2020
Expiry Date
December 08, 2025
Product Models
Genscreen HIV-1 Ag Assay (71120), Genscreen HIV-1 Ag Confirmatory Assay (71121)
ๅบๅ ็ญๆฅ HIV-1 ๆๅๆฃๆต (71120)ใๅบๅ ็ญๆฅ HIV-1 ๆๅ็กฎ่ฎคๆฃๆต (71121)