241002
C
current
IVD Test Reagent/Kits, Immunoassay, Rapid Test, Bacteria, Streptococcus Pneumoniae, Antigenไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็, ๅ ็ซๆตๅฎ, ๅฟซ้ๆฃๆต, ็ป่, ่บ็้พ็่, ๆๅ
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Rapid Test, Bacteria, Streptococcus Pneumoniae, Antigen. 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.
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
C
Product Code
N/A
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
United States
็พๅฝ
10 Southgate Road, Scarborough, ME 04074, United States Of America
10 Southgate Road, ๆฏๅกไผฏๅ, ME 04074, ็พๅฝ
Authorised Representative (AR)
Abbott Laboratories Limited
็พๅฝ้
ๅนๅถ่ฏๆ้ๅ
ฌๅธ
25668711, 98615786
Regulatory Timeline
Registration Date
July 23, 2024
Expiry Date
July 22, 2029
Product Models
BinaxNOW Streptococcus pneumoniae Antigen Card (710-100, 710-012), BinaxNOW Streptococcus pneumoniae Control Swab Pack (710-010)
BinaxNOW ่บ็้พ็่ๆๅๅก (710-100, 710-012), BinaxNOW ่บ็้พ็่ๅฏน็
งๆญๅญๅ
(710-010)