240134
C
current
IVD Test Reagent/Kits, Microbiology, Virus, Identification, Cytomegalovirusไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็, ๅพฎ็็ฉๅญฆ, ็ ๆฏ, ้ดๅฎ, ๅทจ็ป่็ ๆฏ
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Microbiology, Virus, Identification, Cytomegalovirus. 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, Microbiology, Virus, Identification, Cytomegalovirus
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็, ๅพฎ็็ฉๅญฆ, ็ ๆฏ, ้ดๅฎ, ๅทจ็ป่็ ๆฏ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
C
Product Code
19513
Product Code Detail
19513 IVD Test Reagent/Kits, Microbiology, Virus, Identification, Cytomegalovirus
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
April 18, 2024
Expiry Date
April 17, 2029
Product Models
cobas CMV (09040897190), cobas CMV Control Kit (09040919190)
cobas ๅทจ็ป่็
ๆฏ (09040897190)ใcobas ๅทจ็ป่็
ๆฏๅฏน็
ง่ฏๅ็ (09040919190)