230284
C
current
IVD Test Reagent/Kits, Serology, Virus, Cytomegalovirus, IgG Antibodyไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใ่กๆธ ๅญฆใ็ ๆฏใๅทจ็ป่็ ๆฏใIgG ๆไฝ
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Serology, Virus, Cytomegalovirus, IgG 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, Cytomegalovirus, IgG Antibody
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใ่กๆธ ๅญฆใ็ ๆฏใๅทจ็ป่็ ๆฏใIgG ๆไฝ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
C
Product Code
19381
Product Code Detail
19381 IVD Test Reagent/Kits, Serology, Virus, Cytomegalovirus, IgG Antibody
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
BioMerieux S.A.
Biomรฉrieux
376, Chemin de I'Orme, 69280 MARCY L ETOILE FRANCE
376, Chemin de I'Orme, 69280 MARCY L ETOILE ่้ฆๅ
ฌๆฅ ANCE
Authorised Representative (AR)
BioMerieux China Ltd.
็็ฉๆข
้ๅไธญๅฝๆ้ๅ
ฌๅธ
23567033
Regulatory Timeline
Registration Date
September 12, 2023
Expiry Date
September 12, 2028
Product Models
VIDAS CMV IgG (30204)
ๅทจ็ป่็
ๆฏๅ
็ซ็่็ฝ็ๅฝ (30204)