Pure Global
220260
B
current

IVD Test Reagent/Kits, Immunoassay, Vitamin, D Metabolite, 25-Hydroxyvitamin Dไฝ“ๅค–่ฏŠๆ–ญ ๆต‹่ฏ•่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€ๅ…็–ซๆต‹ๅฎšใ€็ปด็”Ÿ็ด ใ€D ไปฃ่ฐข็‰ฉใ€25-็พŸๅŸบ็ปด็”Ÿ็ด  D

This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Vitamin, D Metabolite, 25-Hydroxyvitamin D. 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, Immunoassay, Vitamin, D Metabolite, 25-Hydroxyvitamin D

็”ขๅ“่ณ‡่จŠ๏ผš ไฝ“ๅค–่ฏŠๆ–ญ ๆต‹่ฏ•่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€ๅ…็–ซๆต‹ๅฎšใ€็ปด็”Ÿ็ด ใ€D ไปฃ่ฐข็‰ฉใ€25-็พŸๅŸบ็ปด็”Ÿ็ด  D

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
B
Product Code
19142
Product Code Detail
19142 IVD Test Reagent/Kits, Immunoassay, Vitamin, D Metabolite, 25-Hydroxyvitamin D
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
BioMerieux S.A.
Biomรฉrieux
376, Chemin de l'Orme, 69280 MARCY L ETOILE, FRANCE
376, 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
August 31, 2022
Expiry Date
August 31, 2027
Product Models
VIDAS 25 OH Vitamin D Total (30463)
VIDAS 25 OH ็ปด็”Ÿ็ด  D ๆ€ป้‡ (30463)