220142
C
current
IVD Test Reagent/Kits, Serology, Virus, Severe Acute Respiratory Syndrome Coronavirus 2ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใ่กๆธ ๅญฆใ็ ๆฏใไธฅ้ๆฅๆงๅผๅธ็ปผๅๅพๅ ็ถ็ ๆฏ 2
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Serology, Virus, Severe Acute Respiratory Syndrome Coronavirus 2. 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, Severe Acute Respiratory Syndrome Coronavirus 2
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใ่กๆธ ๅญฆใ็ ๆฏใไธฅ้ๆฅๆงๅผๅธ็ปผๅๅพๅ ็ถ็ ๆฏ 2
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
C
Product Code
41570
Product Code Detail
41570 IVD Test Reagent/Kits, Serology, Virus, Severe Acute Respiratory Syndrome Coronavirus 2
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Abbott Ireland Diagnostics Division
Abbott Ireland Diagnostics Division
Ireland
็ฑๅฐๅ
ฐ
Finisklin Business Park, Sligo, Ireland
่ฒๅฐผๆฏๅ
ๆๅไธๅญ,็ฑๅฐๅ
ฐๆฏ่ฑๆ
Authorised Representative (AR)
Abbott Laboratories Limited
็พๅฝ้
ๅนๅถ่ฏๆ้ๅ
ฌๅธ
25668711, 98615786
Regulatory Timeline
Registration Date
April 29, 2022
Expiry Date
April 29, 2027
Product Models
Alinity i SARS-CoV-2 IgG II Quant Calibrator Kit ((06S61-02)), Alinity i SARS-CoV-2 IgG II Quant Control Kit ((06S61-12)), Alinity i SARS-CoV-2 IgG II Quant Reagent Kit ((06S61-22)), Alinity i SARS-CoV-2 IgG II Quant Reagent Kit ((06S61-32))
้ๆง i SARS-CoV-2 IgG II ๅฎ้ๆ กๅ่ฏๅ็ ((06S61-02)), ้ๆง i SARS-CoV-2 IgG II ๅฎ้ๅฏน็
ง่ฏๅ็ ((06S61-12)), ้ๆง i SARS-CoV-2 IgG II ๅฎ้่ฏๅ็ ((06S61-22)), ้ๆง i SARS-CoV-2 IgG II ๅฎ้่ฏๅ็ ((06S61-32))