240201
C
current
IVD Test Reagent/Kits, Immunoassay, Brain Traumaไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็ใๅ ็ซๆตๅฎใ่ๅคไผค
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Brain Trauma. 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, Immunoassay, Brain Trauma
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็ใๅ ็ซๆตๅฎใ่ๅคไผค
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
C
Product Code
40103
Product Code Detail
40103 IVD Test Reagent/Kits, Immunoassay, Brain Trauma
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Abbott Ireland Diagnostics Division
Abbott Ireland Diagnostics Division
Finisklin Business Park, Sligo, IRELAND
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ๆๅไธๅญ,็ฑๅฐๅ
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Authorised Representative (AR)
Abbott Laboratories Limited
็พๅฝ้
ๅนๅถ่ฏๆ้ๅ
ฌๅธ
25668711, 98615786
Regulatory Timeline
Registration Date
June 04, 2024
Expiry Date
June 03, 2029
Product Models
GFAP Reagent Kit (4W16-25), GFAP Calibrators (4W16-01), GFAP Controls (4W16-10), UCH-L1 Reagent Kit (4W18-25), UCH-L1 Calibrators (4W18-01), UCH-L1 Controls (4W18-10), TBI (04Z22)
GFAP ่ฏๅ็ (4W16-25)ใGFAP ๆ กๅๅ (4W16-01)ใGFAP ่ดจๆงๅ (4W16-10)ใUCH-L1 ่ฏๅ็ (4W18-25)ใUCH-L1 ่ดจ่ฏๅ็ (4W18-01)ใUCH-L1 ่ดจๆงๅ (4W18-10)ใTBI (04Z22)