200430
D
current
IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antigenไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใ่กๆธ ๅญฆใ็ ๆฏใไนๅ่็ใ่กจ้ขๆๅ
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface 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, Hepatitis B, Surface Antigen
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใ่กๆธ ๅญฆใ็ ๆฏใไนๅ่็ใ่กจ้ขๆๅ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
D
Product Code
17360
Product Code Detail
17360 IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface 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
December 03, 2020
Expiry Date
December 03, 2025
Product Models
Monolisa HBs Ag ULTRA (72346, 72348)
ๅไฝ HBs ้ถ่ถ
(72346, 72348)