240012
C
current
IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Human Papilloma Virusไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใๅๅญๆฃๆตใๆๆใ็ ๆฏใไบบ็ค็ ๆฏ
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Human Papilloma Virus. 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, Human Papilloma Virus
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใๅๅญๆฃๆตใๆๆใ็ ๆฏใไบบ็ค็ ๆฏ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
C
Product Code
19249
Product Code Detail
19249 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Human Papilloma Virus
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
January 23, 2024
Expiry Date
January 23, 2029
Product Models
cobas 4800 HPV Amplification/Detection Kit, 240 Tests (05235901190), cobas 4800 HPV Amplification/Detection Kit, 960 Tests (05235910190), cobas 4800 HPV Controls Kit (05235855190)
cobas 4800 HPV ๆฉๅข/ๆฃๆต่ฏๅ็,240 ๆฌกๆฃๆต (05235901190), cobas 4800 HPV ๆฉๅข/ๆฃๆต่ฏๅ็,960 ๆฌกๆฃๆต (05235910190), cobas 4800 HPV ๅฏน็
ง่ฏๅ็(05235855190)