140349
D
current
IVD Test Reagent/Kits, Serology, Virus, Hepatitis C, Core Antigenไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใ่กๆธ ๅญฆใ็ ๆฏใไธๅ่็ใๆ ธๅฟๆๅ
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Serology, Virus, Hepatitis C, Core 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 C, Core Antigen
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใ่กๆธ ๅญฆใ็ ๆฏใไธๅ่็ใๆ ธๅฟๆๅ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
D
Product Code
19062
Product Code Detail
19062 IVD Test Reagent/Kits, Serology, Virus, Hepatitis C, Core Antigen
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
October 16, 2029
Product Models
ARCHITECT HCV Ag Reagent Kit (6L47-27), ARCHITECT HCV Ag Calibrators (6L47-02), ARCHITECT HCV Ag Controls (6L47-11)
ๅปบ็ญๅธHCVๅไธ่ฏๅ็(6L47-27),ๅปบ็ญๅธHCVๅไธๆ กๅๅจ(6L47-02),ๅปบ็ญๅธHCVๅไธๅฏน็
ง(6L47-11)