241050
B
current
IVD Test Reagent/Kits, Clinical Chemistry, Protein, Total, Cerebrospinal Fluidไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็, ไธดๅบๅๅญฆ, ๆป่็ฝ่ดจ, ่่ๆถฒ
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Clinical Chemistry, Protein, Total, Cerebrospinal Fluid. 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, Clinical Chemistry, Protein, Total, Cerebrospinal Fluid
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็, ไธดๅบๅๅญฆ, ๆป่็ฝ่ดจ, ่่ๆถฒ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
B
Product Code
17294
Product Code Detail
17294 IVD Test Reagent/Kits, Clinical Chemistry, Protein, Total, Cerebrospinal Fluid
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Roche Diagnostics GmbH
Roche Diagnostics Gmbh
Germany
ๅพทๅฝ
Sandhofer Strasse 116, 68305 Mannheim, Germany
Sandhofer Strasse 116, 68305 ๆผๆตทๅง, ๅพทๅฝ
Authorised Representative (AR)
Regulatory Timeline
Registration Date
September 24, 2024
Expiry Date
September 23, 2029
Product Models
Elecsys Total-Tau CSF (08846685190, 08846634190), PreciControl Total-Tau (07357028190), CalSet Total-Tau (07357010190)
Elecsys ๆป Tau ้ CSF (08846685190ใ08846634190)ใPreciControl ๆป Tau ้ (07357028190)ใCalSet ๆป Tau ้ (07357010190)