110240
D
Expired.
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
Expired.
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Hologic, Inc.
Hologic
United States
็พๅฝ
10210 Genetic Center Drive, San Diego, CA 92121, United States
10210้ไผ ไธญๅฟ้ฉฑๅจๅจ, ๅฃๅฐไบๅฅ, CA 92121, ็พ
Authorised Representative (AR)
21613100
Regulatory Timeline
Registration Date
August 23, 2016
Expiry Date
August 23, 2021
Product Models
Procleix Ultrio Plus Assay (302573, 302574, 302575, 302576, 302577, 302571, 302572, 30260, 30261, 303665, 302441, 303666, 301120, 301175)
Procleix Ultrio Plus ๆตๅฎ (302573, 302574, 302575, 302576, 302577, 302571, 302572, 30260, 30261, 303665, 302441, 303666, 301120, 301175)