170119
D
current
IVD Test Reagent/Kits, Serology, Virus, Hepatitis Be, Antigenไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใ่กๆธ ๅญฆใ็ ๆฏใไนๅ่็ใๆๅ
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Serology, Virus, Hepatitis Be, 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 Be, Antigen
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใ่กๆธ ๅญฆใ็ ๆฏใไนๅ่็ใๆๅ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
D
Product Code
19060
Product Code Detail
19060 IVD Test Reagent/Kits, Serology, Virus, Hepatitis Be, 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
May 26, 2021
Expiry Date
June 21, 2026
Product Models
ARCHITECT HBeAg Reagent Kit (6C32-20, 6C32-25, 6C32-27, 6C32-37), ARCHITECT HBeAg Controls (6C32-10), ARCHITECT HBeAg Calibrators (6C32-01), ARCHITECT HBeAg Quantitative Controls (7P24-10), ARCHITECT HBeAg Quantitative Calibrators (7P24-01)
ๅปบ็ญๅธ HBeAg ่ฏๅ็ (6C32-20, 6C32-25, 6C32-27, 6C32-37), ๅปบ็ญๅธ HBeAg ๆงๅถ (6C32-10), ๅปบ็ญๅธ HBeAg ๆ กๅๅจ (6C32-01), ๅปบ็ญๅธ HBeAg ๅฎ้ๅฏน็
ง (7P24-10), ๅปบ็ญๅธ HBeAg ๅฎ้ๆ กๅๅจ (7P24-01)