240008
B
current
IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Clostridium difficile, DNAไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใๅๅญๆตๅฎใๆๆใ็ป่ใ่ฐ้พๆขญ่ใDNA
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Clostridium difficile, DNA. 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, Molecular Assay, Infection, Bacteria, Clostridium difficile, DNA
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใๅๅญๆตๅฎใๆๆใ็ป่ใ่ฐ้พๆขญ่ใDNA
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
B
Product Code
34229
Product Code Detail
34229 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Clostridium difficile, DNA
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
United States
็พๅฝ
1080 US Highway 202 South, Branchburg, NJ 08876, USA
1080 US Highway 202 South, Branchburg, NJ 08876, USA
Authorised Representative (AR)
Regulatory Timeline
Registration Date
January 23, 2024
Expiry Date
January 23, 2029
Product Models
cobas 4800 Cdiff Amplification/Detection Kit, 80 Tests (06768237190), cobas 4800 Cdiff Controls and Cofactor Kit (06768300190)
cobas 4800 Cdiff ๆฉๅข/ๆฃๆต่ฏๅ็,80 ๆฌกๆฃๆต (06768237190),cobas 4800 Cdiff ๅฏน็
งๅๅ่พ
ๅ ๅญ่ฏๅ็(06768300190)