Pure Global
140226
D
Delisted

IVD Test Reagent/Kits, Serology, Virus, Hepatitis C, Antibodyไฝ“ๅค–่ฏŠๆ–ญ่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’๏ผŒ่ก€ๆธ…ๅญฆ๏ผŒ็—…ๆฏ’๏ผŒไธ™ๅž‹่‚็‚Ž๏ผŒๆŠ—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

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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
D
Product Code
17914
State
N/A
Status
Delisted
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Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
BIO-RAD
Bio-Rad
3 boulevard Raymond Poincare, 92430 MARNES LA COQUETTE, FRANCE
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Authorised Representative (AR)
2789 3300 / 63365950
Regulatory Timeline
Registration Date
July 23, 2014
Expiry Date
July 23, 2019
Delist Date
May 24, 2019
Remarks
Delisted.
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Product Models
Access HCV Ab Plus (34330), Access HCV Ab Plus Calibrators (34335), Access HCV Ab Plus QC (34339)