240382
C
current
IVD Test Reagent/Kits, Molecular Assay, Control, Targeted Sequencing, Humanไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็, ๅๅญๆฃๆต, ๅฏน็ ง, ้ถๅๆตๅบ, ไบบ็ฑป
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Molecular Assay, Control, Targeted Sequencing, Human. 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.
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
C
Product Code
N/A
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Microgenics Corporation
Microgenics Corporation
United States
็พๅฝ
46500 Kato Road, Fremont CA 94538, USA
46500 Kato Road, Fremont CA 94538, ็พๅฝ
Authorised Representative (AR)
Thermo Fisher Scientific (Hong Kong) Limited
่ต้ป้ฃไธๅฐ็งๆ(้ฆๆธฏ)ๆ้ๅ
ฌๅธ
31077600
Regulatory Timeline
Registration Date
September 11, 2024
Expiry Date
September 10, 2029
Product Models
AcroMetrix Oncology Hotspot Control (969056)
AcroMetrix Oncology Hotspot Control (969056)

