Pure Global
240188
C
current

IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria/Parasite, Mycoplasma Species/Trichomonas vaginalis, DNAไฝ“ๅค–่ฏŠๆ–ญๆฃ€ๆต‹่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’, ๅˆ†ๅญๆฃ€ๆต‹, ๆ„ŸๆŸ“, ็ป†่Œ/ๅฏ„็”Ÿ่™ซ, ๆ”ฏๅŽŸไฝ“/้˜ด้“ๆฏ›ๆปด่™ซ, DNA

This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria/Parasite, Mycoplasma Species/Trichomonas vaginalis, 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, Parasite, Trichomonas vaginalis, DNA

็”ขๅ“่ณ‡่จŠ๏ผš ไฝ“ๅค–่ฏŠๆ–ญๆฃ€ๆต‹่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’, ๅˆ†ๅญๆฃ€ๆต‹, ๆ„ŸๆŸ“, ๅฏ„็”Ÿ่™ซ, ้˜ด้“ๆฏ›ๆปด่™ซ, DNA

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
C
Product Code
22149
Product Code Detail
22149 IVD Test Reagent/Kits, Molecular Assay, Infection, Parasite, Trichomonas vaginalis, 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
May 21, 2024
Expiry Date
May 20, 2029
Product Models
cobas TV/MG (09040633190), cobas TV/MG Positive Control Kit (09040641190)
cobas TV/MG (09040633190)ใ€cobas TV/MG ้˜ณๆ€งๅฏน็…งๅฅ—ไปถ (09040641190)