240010
C
current
IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Chlamydia trachomatis/Neisseria gonorrhoeae, DNAไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใๅๅญๆตๅฎใๆๆใ็ป่ใๆฒ็ผ่กฃๅไฝ/ๆท็ ๅฅ็่ใDNA
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Chlamydia trachomatis/Neisseria gonorrhoeae, 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, Chlamydia trachomatis/Neisseria gonorrhoeae, DNA
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใๅๅญๆตๅฎใๆๆใ็ป่ใๆฒ็ผ่กฃๅไฝ/ๆท็ ๅฅ็่ใDNA
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
C
Product Code
21515
Product Code Detail
21515 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Chlamydia trachomatis/Neisseria gonorrhoeae, 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 CT/NG Amplification/Detection Kit, 960 Tests (05235979190), cobas 4800 CT/NG Amplification/Detection Kit, 240 Tests (05235952190), cobas 4800 CT/NG Controls Kit (05235928190)
cobas 4800 CT/NG ๆฉๅข/ๆฃๆต่ฏๅ็,960 ๆฌกๆฃๆต (05235979190), cobas 4800 CT/NG ๆฉๅข/ๆฃๆต่ฏๅ็,240 ๆฌกๆฃๆต (05235952190), cobas 4800 CT/NG ๅฏน็
ง่ฏๅ็ (05235928190)