Pure Global
220340
C
current

IVD Test Reagent/Kits, Immunoassay, Protein, Procalcitoninไฝ“ๅค–่ฏŠๆ–ญ ๆต‹่ฏ•่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€ๅ…็–ซๆต‹ๅฎšใ€่›‹็™ฝ่ดจใ€้™้’™็ด ๅŽŸ

This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Protein, Procalcitonin. 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, Protein, Procalcitonin

็”ขๅ“่ณ‡่จŠ๏ผš ไฝ“ๅค–่ฏŠๆ–ญ ๆต‹่ฏ•่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€ๅ…็–ซๆต‹ๅฎšใ€่›‹็™ฝ่ดจใ€้™้’™็ด ๅŽŸ

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
C
Product Code
25106
Product Code Detail
25106 IVD Test Reagent/Kits, Immunoassay, Protein, Procalcitonin
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
France
ๆณ•ๅ›ฝ
376, Chemin de l'Orme, 69280 Marcy L Etoile France
376, Chemin de l'Orme, 69280 Marcy L Etoile France
Authorised Representative (AR)
BioMerieux China Ltd.
็”Ÿ็‰ฉๆข…้‡ŒๅŸƒไธญๅ›ฝๆœ‰้™ๅ…ฌๅธ
23567033
Regulatory Timeline
Registration Date
October 18, 2022
Expiry Date
October 18, 2027
Product Models
VIDAS B.R.A.H.M.S PCT (30450)
B.R.A.H.M.S PCT LIVES (30450)