120108
D
current
IVD Test Reagent/Kits, Serology, Virus, Hepatitis C, Antibodyไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใ่กๆธ ๅญฆใ็ ๆฏใไธๅ่็ใๆไฝ
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Serology, Virus, Hepatitis C, Antibody. 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, Hepatitis C, Antibody
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใ่กๆธ ๅญฆใ็ ๆฏใไธๅ่็ใๆไฝ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
D
Product Code
17914
Product Code Detail
17914 IVD Test Reagent/Kits, Serology, Virus, Hepatitis C, Antibody
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Ortho-Clinical Diagnostics
Ortho-Clinical Diagnostics, Inc.
United Kingdom
่ฑๅฝ
Felindre Meadows, Pencoed, Bridgend CF35 5PZ, United Kingdom
Felindre Meadows, Pencoed, Bridgend CF35 5PZ, ่ฑๅฝ
Authorised Representative (AR)
DCH Auriga (Hong Kong) Limited
ๅฅฅๅฉไฝณ(้ฆๆธฏ)ๆ้ๅ
ฌๅธ
36192800
Regulatory Timeline
Registration Date
February 16, 2022
Expiry Date
April 27, 2027
Product Models
Vitros Immunodiagnostic Products Anti-HCV Reagent Pack (1318450), Vitros Immunodiagnostic Products Anti-HCV Calibrator (1940667), Vitros Immunodiagnostic Products Anti-HCV Controls (6800731)
ไฝๅคๅ
็ซ่ฏๆญไบงๅ ๆไธ่็
ๆฏ่ฏๅๅ
(1318450), ไฝๅคๅ
็ซ่ฏๆญไบงๅ ๆไธ่็
ๆฏๆ กๅๅ (1940667), ไฝๅคๅ
็ซ่ฏๆญไบงๅ ๆไธ่ๅฏน็
ง (6800731)