180261
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 Diagnostic Solutions Inc.
Grifols Diagnostic Solutions Inc.
United States
็พๅฝ
4560 Horton Street, Emeryville, California 94608, USA
4560้้กฟ่ก,ๅ้ป้็ปดๅฐ,ๅ ๅฉ็ฆๅฐผไบๅท94608,็พๅฝ
Authorised Representative (AR)
21613100
Regulatory Timeline
Registration Date
June 14, 2023
Expiry Date
August 21, 2028
Product Models
Procleix Ultrio Elite Assay (303330, 303715), Procleix Ultrio Elite HIV, HCV and HBV Discriminatory Probe Reagents (303334), Procleix Ultrio Elite Target Enhancer Reagent (303331, 303722), Procleix Ultrio Elite Negative Calibrators (303333), Procleix Ultrio Elite Positive Calibrators (303332), Procieix Ultrio Elite Assay Calibrators Kit (303719, 303723)
Procleix Ultrio Elite ๆฃๆต่ฏๅ็ (303330, 303715), Procleix Ultrio Elite HIVใHCV ๅ HBV ้ดๅซๆข้่ฏๅ (303334), Procleix Ultrio Elite ้ถๆ ๅขๅผบ่ฏๅ (303331, 303722), Procleix Ultrio Elite Negative Basecover (303333), Procleix Ultrio Elite Positive Basec 303332), Procieix Ultrio Elite Agtest ๆฃๆตๆ กๅๅ่ฏๅ็ (303719, 303723)