240009
C
current
IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Staphylococcus aureus, DNA, Antimicrobial-Resistantไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใๅๅญๆตๅฎใๆๆใ็ป่ใ้้ป่ฒ่ก่็่ใDNAใๆ่่่ฏๆง
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Staphylococcus aureus, DNA, Antimicrobial-Resistant. 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, Staphylococcus aureus, DNA, Antimicrobial-Resistant
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใๅๅญๆตๅฎใๆๆใ็ป่ใ้้ป่ฒ่ก่็่ใDNAใๆ่่่ฏๆง
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
C
Product Code
21666
Product Code Detail
21666 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Staphylococcus aureus, DNA, Antimicrobial-Resistant
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 MRSA/SA Amplification/Detection Kit, 240 Tests (06768172190), cobas 4800 MRSA/SA Amplification/Detection Kit, 80 Tests (06768113190), cobas 4800 MRSA/SA Controls and Cofactor Kit (06768288190)
cobas 4800 MRSA/SA ๆฉๅข/ๆฃๆต่ฏๅ็,240 ๆฌกๆฃๆต (06768172190),cobas 4800 MRSA/SA ๆฉๅข/ๆฃๆต่ฏๅ็,80 ๆฌกๆฃๆต (06768113190),cobas 4800 MRSA/SA ๅฏน็
งๅๅ่พ
ๅ ๅญ่ฏๅ็(06768288190)