180173
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)
Abbott GmbH & Co. KG
Abbott Gmbh
Germany
ๅพทๅฝ
Max-Planck-Ring 2, 65205 Wiesbaden, Germany
้ฉฌๅ
ๆฏ-ๆฎๆๅ
็ฏ 2, 65205 ๅจๆฏๅทด็ป, ๅพทๅฝ
Authorised Representative (AR)
Abbott Laboratories Limited
็พๅฝ้
ๅนๅถ่ฏๆ้ๅ
ฌๅธ
25668711, 98615786
Regulatory Timeline
Registration Date
April 04, 2023
Expiry Date
June 11, 2028
Product Models
Alinity i Anti-HCV Reagent Kit (08P0622, 08P0632), Alinity i Anti-HCV Calibrator (08P0601), Alinity i Anti-HCV Controls (08P0610)
Alinity i ๆ HCV ่ฏๅ็ (08P0622, 08P0632), Alinity i ๆ HCV ๆ กๅๅ (08P0601), Alinity i ๆ HCV ๅฏน็
ง (08P0610)