140399
D
current
IVD Test Reagent/Kits, Serology, Virus, Retrovirus, HIV-1/2ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใ่กๆธ ๅญฆใ็ ๆฏใ้่ฝฌๅฝ็ ๆฏใHIV-1/2
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Serology, Virus, Retrovirus, HIV-1/2. 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
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใ่กๆธ ๅญฆใ็ ๆฏใ้่ฝฌๅฝ็ ๆฏใHIV-1/2
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
D
Product Code
19430
Product Code Detail
19430 IVD Test Reagent/Kits, Serology, Virus, Retrovirus, HIV-1/2
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
BIO-RAD LABORATORIES CLINICAL DIAGNOSTICS GROUP
BIO-RAD LABORATORIES CLINICAL DIAGNOSTICS GROUP
4000 Alfred Nobel Drive, HERCULES, CA - 94547, UNITED STATES
4000้ฟๅฐๅผ้ทๅพท่ฏบ่ดๅฐ้ฉฑๅจๅจ, ่ตซๆๅ
ๅๆฏ, CA - 94547, ็พๅฝ
Authorised Representative (AR)
2789 3300 / 63365950
Regulatory Timeline
Registration Date
October 07, 2024
Expiry Date
November 13, 2029
Product Models
BioPlex 2200 HIV Ag-Ab (665-3450), BioPlex 2200 HIV Ag-Ab Calibrator set (663-3400), BioPlex 2200 HIV Ag-Ab Control set (663-3430)
BioPlex 2200 HIV Ag-Ab (665-3450)ใBioPlex 2200 HIV Ag-Ab ๆ กๅๅๅฅ่ฃ
(663-3400)ใBioPlex 2200 HIV Ag-Ab ๅฏน็
งๅฅ่ฃ
(663-3430)