240200
C
current
IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Respiratory Syncytial Virus/Influenza A/B, RNAไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็, ๅๅญๆฃๆต, ็ ๆฏ, ๅผๅธ้ๅ่็ ๆฏ/็ฒๅ/ไนๅๆตๆ, RNA
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Respiratory Syncytial Virus/Influenza A/B, RNA. 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)
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
United States
็พๅฝ
1080 US Highway 202 South, Branchburg, New Jersey, 08876, USA
1080 US Highway 202 South, ๅธๅ
ฐๅฅๅ ก, ๆฐๆณฝ่ฅฟๅท, 08876, ็พๅฝ
Authorised Representative (AR)
Regulatory Timeline
Registration Date
June 04, 2024
Expiry Date
June 03, 2029
Product Models
cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System (08160104190), cobas Influenza A/B & RSV Quality Control Kit for use on the cobas Liat System (07402686190)
cobas ็ฒๅ/ไนๅๆตๆๅ RSV ๆ ธ้
ธๆฃๆต,็จไบ cobas Liat ็ณป็ป (08160104190),cobas ็ฒๅๆตๆ & RSV ่ดจๆง่ฏๅ็,็จไบ cobas Liat ็ณป็ป (07402686190)