Pure Global
240382
C
current

IVD Test Reagent/Kits, Molecular Assay, Control, Targeted Sequencing, Humanไฝ“ๅค–่ฏŠๆ–ญๆฃ€ๆต‹่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’, ๅˆ†ๅญๆฃ€ๆต‹, ๅฏน็…ง, ้ถๅ‘ๆต‹ๅบ, 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
Pure Global
DJ Fang

DJ Fang

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Manufacturer (่ฃฝ้€ ๅ•†)
Microgenics Corporation
Microgenics Corporation
United States
็พŽๅ›ฝ
46500 Kato Road, Fremont CA 94538, USA
46500 Kato Road, Fremont CA 94538, ็พŽๅ›ฝ
Authorised Representative (AR)
Thermo Fisher Scientific (Hong Kong) Limited
่ต›้ป˜้ฃžไธ–ๅฐ”็ง‘ๆŠ€(้ฆ™ๆธฏ)ๆœ‰้™ๅ…ฌๅธ
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)