240053
C
current
IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, BK Virus, DNAไฝๅค่ฏๆญ่ฏๅ/่ฏๅ็, ๅๅญๆฃๆต, ๆๆ, ็ ๆฏ, BK็ ๆฏ, DNA
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, BK Virus, DNA. 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, BK Virus, DNA
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ่ฏๅ/่ฏๅ็, ๅๅญๆฃๆต, ๆๆ, ็ ๆฏ, BK็ ๆฏ, DNA
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
C
Product Code
22265
Product Code Detail
22265 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, BK Virus, DNA
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, New Jersey 08876, USA
1080 US Highway 202 South, ๅธๅ
ฐๅฅๅ ก, ๆฐๆณฝ่ฅฟๅท 08876, ็พๅฝ
Authorised Representative (AR)
Regulatory Timeline
Registration Date
February 19, 2024
Expiry Date
February 18, 2029
Product Models
cobas BKV (09040960190), cobas EBV/BKV Control Kit (09040951190)
cobas BKV (09040960190), cobas EBV/BKV ๆงๅถๅฅไปถ (09040951190)