Pure Global
240055
C
current

IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Human Papilloma Virus, DNAไฝ“ๅค–่ฏŠๆ–ญ่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’,ๅˆ†ๅญๆต‹ๅฎš,ๆ„ŸๆŸ“,็—…ๆฏ’,ไบบ็˜ค็—…ๆฏ’,DNA

This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Human Papilloma Virus, 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, Virus, Human Papilloma Virus, DNA

็”ขๅ“่ณ‡่จŠ๏ผš ไฝ“ๅค–่ฏŠๆ–ญ่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’,ๅˆ†ๅญๆต‹ๅฎš,ๆ„ŸๆŸ“,็—…ๆฏ’,ไบบ็˜ค็—…ๆฏ’,DNA

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
C
Product Code
22304
Product Code Detail
22304 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Human Papilloma Virus, DNA
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
United States
็พŽๅ›ฝ
1080 US Highway 202 South, Branchburg, New Jersey, 08876, USA
1080 US Highway 202 South, ๅธƒๅ…ฐๅฅ‡ๅ ก, ๆ–ฐๆณฝ่ฅฟๅทž, 08876, ็พŽๅ›ฝ
Authorised Representative (AR)
24813387
Regulatory Timeline
Registration Date
February 19, 2024
Expiry Date
February 18, 2029
Product Models
cobas HPV (09040544190), cobas HPV Positive Control Kit (09040552190)
cobas HPV (09040544190), cobas HPV ้˜ณๆ€งๅฏน็…ง่ฏ•ๅ‰‚็›’ (09040552190)