190271
D
current
IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Zikaไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใๅๅญๆฃๆตใๆๆใ็ ๆฏใๅฏจๅก็ ๆฏ
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Zika. 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, Zika
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใๅๅญๆฃๆตใๆๆใ็ ๆฏใๅฏจๅก็ ๆฏ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
D
Product Code
37128
Product Code Detail
37128 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Zika
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
August 16, 2024
Expiry Date
September 02, 2029
Product Models
Procleix Zika Virus Assay Kit (PRD-04170, PRD-04228), Procleix Zika Virus Assay Calibrators Kit (PRD-04171, PRD-04229), Procleix Assay Fluids Kit (303344), Procleix Auto Detect Reagents Kit (303345)
Procleix ๅฏจๅก็
ๆฏๆฃๆต่ฏๅ็ (PRD-04170, PRD-04228), Procleix ๅฏจๅก็
ๆฏๆฃๆตๆ กๅ่ฏๅ็ (PRD-04171, PRD-04229), Procleix ๆฃๆตๆถฒ่ฏๅ็ (303344), Procleix ่ชๅจๆฃๆต่ฏๅ็ (303345)