240243
D
current
IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Hepatitis Cไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็ใๅๅญๆตๅฎใๆๆใ็ ๆฏใไธๅ่็
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Hepatitis C. 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, Hepatitis C
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็ใๅๅญๆตๅฎใๆๆใ็ ๆฏใไธๅ่็
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
D
Product Code
19244
Product Code Detail
19244 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Hepatitis C
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
United States
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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
July 11, 2024
Expiry Date
July 10, 2029
Product Models
cobas HCV (09040765190)
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ๆฏ (09040765190)