190376
D
current
IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Core Antibodyไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใ่กๆธ ๅญฆใ็ ๆฏใไนๅ่็ใๆ ธๅฟๆไฝ
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Core 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 B, Core Antibody
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใ่กๆธ ๅญฆใ็ ๆฏใไนๅ่็ใๆ ธๅฟๆไฝ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
D
Product Code
17355
Product Code Detail
17355 IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Core 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
July 24, 2024
Expiry Date
November 25, 2029
Product Models
Alinity i Anti-HBc II Reagent Kit (07P8722, 07P8732) \r\nAlinity i Anti-HBc II Calibrator (07P8701)\r\nAlinity i Anti-HBc II Control (07P8710)\r\n
Alinity i ๆ HBc II ่ฏๅ็ (07P8722, 07P8732) \r\nAlinity i ๆ HBc II ๆ กๅๅ (07P8701)\r\nAlinity i ๆ HBc II ๅฏน็
งๅ (07P8710)\r\n