240244
D
current
IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Retrovirus, HIVไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็ใๅๅญๆตๅฎใๆๆใ็ ๆฏใ้่ฝฌๅฝ็ ๆฏใ่พๆป็ ๆฏ
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Retrovirus, HIV. 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, Molecular Assay, Infection, Virus, Retrovirus, HIV
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็ใๅๅญๆตๅฎใๆๆใ็ ๆฏใ้่ฝฌๅฝ็ ๆฏใ่พๆป็ ๆฏ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
D
Product Code
19245
Product Code Detail
19245 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Retrovirus, HIV
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
United States
็พๅฝ
1080 US Highway 202 South, Branchburg, NJ 08876, USA
1080 US Highway 202 South, Branchburg, NJ 08876, USA
Authorised Representative (AR)
Regulatory Timeline
Registration Date
July 11, 2024
Expiry Date
July 10, 2029
Product Models
cobas HIV-1 (09040803190)
่พๆป็
ๆฏ-1 (09040803190)