120326
D
current
IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antigenไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใ่กๆธ ๅญฆใ็ ๆฏใไนๅ่็ใ่กจ้ขๆๅ
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antigen. 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 B, Surface Antigen
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใ่กๆธ ๅญฆใ็ ๆฏใไนๅ่็ใ่กจ้ขๆๅ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
D
Product Code
17360
Product Code Detail
17360 IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antigen
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
June 28, 2022
Expiry Date
September 18, 2027
Product Models
VITROS Immunodiagnostic Products HBsAg Reagent Pack (8435307), HBsAg Calibrator (1421932)
ไฝๅคๅ
็ซ่ฏๆญไบงๅ HBsAg ่ฏๅๅ
(8435307), HBsAg ๆ กๅๅ (1421932)