Pure Global
210019
D
current

HIV1/HIV2 antigen/antibody IVD, kit, enzyme immunoassay (EIA)HIV1/HIV2 ๆŠ—ๅŽŸ/ๆŠ—ไฝ“ไฝ“ๅค–่ฏŠๆ–ญใ€่ฏ•ๅ‰‚็›’ใ€้…ถๅ…็–ซๆต‹ๅฎš (EIA)

This profile provides complete Hong Kong MDACS registration information for HIV1/HIV2 antigen/antibody IVD, kit, enzyme immunoassay (EIA). 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.

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
D
Product Code
N/A
State
current
Status
N/A
Pure Global
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Manufacturer (่ฃฝ้€ ๅ•†)
BIO-RAD
Bio-Rad
3 Boulevard Raymond Poincarรฉ, 92430 MARNES LA COQUETTE, FRANCE
3 ๅคง้“้›ท่’™ๅพทๅบžๅŠ ่Žฑ, 92430 ้ฉฌๆฉๆ–ฏๆ‹‰็ง‘ๅจ‡็‰น, ่”้‚ฆๅ…ฌๆŠฅ ๅฎ‰ๆ–ฏ
Authorised Representative (AR)
2789 3300 / 63365950
Regulatory Timeline
Registration Date
February 03, 2021
Expiry Date
February 03, 2026
Product Models
Genscreen ULTRA HIV Ag-Ab (72386, 72388)
Genscreen ULTRA HIV Ag-Ab (72386, 72388)