Taiwan FDA registration 0ef2c0485d3c948afff91994b2ce9121
"Quick" Solana Nucleic Acid Rapid Tester
TW: “快得利” 索拉娜核酸快速檢測儀
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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