180523
D
current
IVD Test Reagent/Kits, Molecular Assay, Nucleic Acid Probeไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใๅๅญๆฃๆต่ฏๅ็ใๆ ธ้ ธๆข้
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Molecular Assay, Nucleic Acid Probe. 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, Nucleic Acid Probe
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใๅๅญๆฃๆต่ฏๅ็ใๆ ธ้ ธๆข้
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
D
Product Code
19666
Product Code Detail
19666 IVD Test Reagent/Kits, Molecular Assay, Nucleic Acid Probe
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Grifols Diagnostics Solutions Inc.
Grifols Diagnostics Solutions Inc.
United States
็พๅฝ
4560 Horton Street, Emeryville, California 94608, United States
4560 Horton Street, ๅ้ป้็ปดๅฐ, ๅ ๅฉ็ฆๅฐผไบๅท 94608, ็พ
Authorised Representative (AR)
21613100
Regulatory Timeline
Registration Date
June 14, 2023
Expiry Date
December 06, 2028
Product Models
Procleix Ultrio Plus Assay 1000/5000 Test Kit (302573, 302574), Procleix Ultrio Plus Assay Calibrators (302575), Procleix Ultrio Plus HBV Discriminatory Probe (302576), Procleix Ultrio Plus HCV Discriminatory Probe (302577), Procleix Ultrio Plus HIV-1 Discriminatory Probe (302571), Procleix Ultrio Plus Tigris Controls Kit (302572), Procleix Ultrio Plus Negative Calibrator Kit (303260), Procleix Ultrio Plus Tigris Negative Controls Kit (303261), Procleix Ultrio Plus HIV-1/HCV/HBV Discriminatory Probe Reagent Kit (PRD-03709), Procleix Wash Solution Kit (303665), Procleix Oil Kit (302441), Procleix Buffer for Deactivation Fluid Kit (303666), Procleix Auto Detect Reagents Kit (301120), Procleix System Fluid Preservative (301175)
Procleix Ultrio Plus ๆฃๆต 1000/5000 ๆฃๆต่ฏๅ็ (302573, 302574), Procleix Ultrio Plus ๆฃๆตๆ กๅๅ (302575), Procleix Ultrio Plus HBV ๅคๅซๆข้ (302576), Procleix Ultrio Plus HCV ๅคๅซๆข้ (302577), Procleix Ultrio Plus HIV-1 ๅคๅซๆข้ (302571), Procleix Ultrio Plus ๅบๆ ผ้ๆฏๅฏน็
ง่ฏๅ็ (302572), Procleix Ultrio Plus ้ดๆงๆ กๅ่ฏๅ็ (303260), Procleix Ultrio Plus ๅบๆ ผ้ๆฏ้ดๆงๅฏน็
ง่ฏๅ็ (303261), Procleix Ultrio Plus HIV-1/HCV/HBV ้ดๅซๆข้่ฏๅ็ (PRD-03709)ใProcleix ๆดๆถคๆถฒ่ฏๅ็ (303665)ใProcleix ๆฒน่ฏๅ็ (302441)ใ็จไบๅคฑๆดปๆถฒ็ Procleix ็ผๅฒๆถฒ่ฏๅ็ (303666)ใProcleix ่ชๅจๆฃๆต่ฏๅ็ (301120)ใProcleix ็ณป็ปๆตไฝ้ฒ่
ๅ (301175)