Taiwan FDA registration 0ef2c0485d3c948afff91994b2ce9121

"Quick" Solana Nucleic Acid Rapid Tester

TW: “快得利” 索拉娜核酸快速檢測儀
Taiwan flagTaiwan·Risk Class 2·QUIDEL CORPORATION·Registered Aug 17, 2023 – Aug 17, 2028Active
Registration details
Analysis ID
0ef2c0485d3c948afff91994b2ce9121
Customs Code
DHA05603621407
Company information
Manufacturer
QUIDEL CORPORATION
Manufacturer Country
United States
Authorized Representative
BIO-CHECK LABORATORIES LTD.
Product details
Intended Use
This product is a rapid detector with a constant temperature nucleic acid amplification reaction and a fluorescent probe, which is suitable for the analysis of Solana nucleic acid rapid test series to assist in disease diagnosis.
Product Type (Level 1)
A Clinical chemistry and clinical toxicology
Product Type (Level 2)
A.2570 Clinical Multi-standard Detection System Instrument
Import Information
Input;; QMS/QSD
Dates and status
Registration Date
Aug 17, 2023
Expiry Date
Aug 17, 2028
About this record

Access comprehensive regulatory information for "Quick" Solana Nucleic Acid Rapid Tester in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 0ef2c0485d3c948afff91994b2ce9121 and manufactured by QUIDEL CORPORATION. The authorized representative in Taiwan is BIO-CHECK LABORATORIES LTD..

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