240342
B
current
IVD Test Reagent/Kits, Serology, Bacteria, Streptococcus Species, Antibody, Streptolysin Oไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็, ่กๆธ ๅญฆ, ็ป่, ้พ็่ๅฑ, ๆไฝ, ้พ็่ๆบถ่ก็ด O
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Serology, Bacteria, Streptococcus Species, Antibody, Streptolysin O. 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, Bacteria, Streptococcus Species, Antibody, Streptolysin O
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็, ่กๆธ ๅญฆ, ็ป่, ้พ็่ๅฑ, ๆไฝ, ้พ็่ๆบถ่ก็ด O
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
B
Product Code
19329
Product Code Detail
19329 IVD Test Reagent/Kits, Serology, Bacteria, Streptococcus Species, Antibody, Streptolysin O
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Siemens Healthcare Diagnostic Inc.
Siemens Healthcare Diagnostic Inc.
United States
็พๅฝ
511 Benedict Ave, Tarrytown NY 10591, USA
511ๆฌๅฐผ่ฟชๅ
็นๅคง้,็บฝ็บฆๅก้ๆฆ10591,็พๅฝ
Authorised Representative (AR)
Siemens Healthcare Limited
่ฅฟ้จๅญๅป็ๆ้ๅ
ฌๅธ
25833388
Regulatory Timeline
Registration Date
August 08, 2024
Expiry Date
August 07, 2029
Product Models
Atellica CH Anti-Streptolysin-O_3 (ASO_3) (11537212)
Atellica CHๆ้พ็่ๆบถ่ก็ด -O_3(ASO_3) (11537212)