Pure Global
120593
D
Expired.

IVD Test Reagent/Kits, Serology, Virus, Hepatitis C, Antibodyไฝ“ๅค–่ฏŠๆ–ญ ๆฃ€ๆต‹่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€่ก€ๆธ…ๅญฆใ€็—…ๆฏ’ใ€ไธ™ๅž‹่‚็‚Žใ€ๆŠ—ไฝ“

This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Serology, Virus, Hepatitis C, Antibody. 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, Serology, Virus, Hepatitis C, Antibody

็”ขๅ“่ณ‡่จŠ๏ผš ไฝ“ๅค–่ฏŠๆ–ญ ๆฃ€ๆต‹่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€่ก€ๆธ…ๅญฆใ€็—…ๆฏ’ใ€ไธ™ๅž‹่‚็‚Žใ€ๆŠ—ไฝ“

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
D
Product Code
17914
Product Code Detail
17914 IVD Test Reagent/Kits, Serology, Virus, Hepatitis C, Antibody
State
Expired.
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
BIOMERIEUX S.A.
Biomรฉrieux
Chemin de l'Orme, 69280 MARCY L ETOILE, FRANCE
Chemin de l'Orme, 69280 MARCY L ETOILE, ่”้‚ฆๅ…ฌๆŠฅ ANCE
Authorised Representative (AR)
BioMerieux China Ltd.
็”Ÿ็‰ฉๆข…้‡ŒๅŸƒไธญๅ›ฝๆœ‰้™ๅ…ฌๅธ
23567033
Regulatory Timeline
Registration Date
March 28, 2013
Expiry Date
March 28, 2018
Product Models
VIDAS Anti-HCV (30308)
ๆŠ—ไธ™่‚็—…ๆฏ’็”Ÿๅ‘ฝ (30308)