Pure Global
240339
B
current

IVD Test Reagent/Kits, Clinical Chemistry, Alcohol Levelไฝ“ๅค–่ฏŠๆ–ญๆฃ€ๆต‹่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€ไธดๅบŠๅŒ–ๅญฆใ€้…’็ฒพๅซ้‡

This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Clinical Chemistry, Alcohol Level. 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, Clinical Chemistry, Alcohol Level

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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
B
Product Code
18930
Product Code Detail
18930 IVD Test Reagent/Kits, Clinical Chemistry, Alcohol Level
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

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Pricing
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
August 08, 2024
Expiry Date
August 07, 2029
Product Models
DRI Ethyl Alcohol Assay (10016397, 0037, 0038), DRI Negative Alcohol Calibrator (0311, 1405), DRI 100 mg/dL Alcohol Calibrator (0241, 1406), DRI 50 mg/dL Alcohol Control (0239), DRI 300 mg/dL Alcohol Control (0243)
DRI ไน™้†‡ๆต‹ๅฎš (10016397, 0037, 0038), DRI ้˜ดๆ€ง้…’็ฒพๆ กๅ‡†ๅ“ (0311, 1405), DRI 100 mg/dL ้…’็ฒพๆ กๅ‡†ๅ“ (0241, 1406), DRI 50 mg/dL ้…’็ฒพๅฏน็…งๅ“ (0239), DRI 300 mg/dL ้…’็ฒพๅฏน็…งๅ“ (0243)