180033
D
Delisted
IVD Test Reagent/Kits, Molecular Assay, Nucleic Acid ProbeIVDๆฃๆต่ฏๅ/่ฏๅ็ใๅๅญๆฃๆตใๆ ธ้ ธๆข้
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Molecular Assay, Nucleic Acid Probe. 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, Nucleic Acid Probe
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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
D
Product Code
19666
State
N/A
Status
Delisted
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Manufacturer (่ฃฝ้ ๅ)
Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
United States
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1080 US Highway 202, South Branchburg, NJ 08876, USA
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ฌ่ทฏ1080๏ผ้ฎๆฟ็ผ็ 08876
Authorised Representative (AR)
Regulatory Timeline
Registration Date
February 20, 2018
Expiry Date
February 20, 2023
Delist Date
March 03, 2023
Remarks
Delisted.
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Product Models
cobas TaqScreen MPX Test, v2.0 (05969492190), cobas TaqScreen MPX Control Kit, v2.0 (05965411190), cobas TaqScreen Wash Reagent (04404220190)