180262
D
current
IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, West Nile Virus, RNAไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใๅๅญๆฃๆตใๆๆใ็ ๆฏใ่ฅฟๅฐผ็ฝๆฒณ็ ๆฏใRNA
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, West Nile Virus, RNA. 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, Molecular Assay, Infection, Virus, West Nile Virus, RNA
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใๅๅญๆฃๆตใๆๆใ็ ๆฏใ่ฅฟๅฐผ็ฝๆฒณ็ ๆฏใRNA
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
D
Product Code
22343
Product Code Detail
22343 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, West Nile Virus, RNA
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Grifols Diagnostic Solutions Inc.
Grifols Diagnostic Solutions Inc.
United States
็พๅฝ
4560 Horton Street, Emeryville, CA 94608 USA
4560้้กฟ่ก,ๅ้ป้็ปดๅฐ,CA 94608 ็พๅฝ
Authorised Representative (AR)
21613100
Regulatory Timeline
Registration Date
June 14, 2023
Expiry Date
August 21, 2028
Product Models
Procleix WNV Assay (302181, 303665, 302441, 303666, 301120, 301186, 301185)
Procleix WNV ๆตๅฎ (302181, 303665, 302441, 303666, 301120, 301186, 301185)