Taiwan FDA registration dc9d6ca7f8bd872496bebc611d3fa261
"Quick" Solana Herpes simplex virus type 1/2 nucleic acid detection reagent
TW: “快得利” 索拉娜 第1/2型單純皰疹/帶狀皰疹病毒核酸檢測試劑
Registration details
- Analysis ID
- dc9d6ca7f8bd872496bebc611d3fa261
- Customs Code
- DHA05603619707
Company information
- Manufacturer
- QUIDEL CORPORATION
- Manufacturer Country
- United States
- Authorized Representative
- BIO-CHECK LABORATORIES LTD.
Product details
- Intended Use
- This product is a qualitative in vitro detection reagent using constant temperature amplification technology to isolate and purify the DNA of herpes simplex virus type 1/2 / herpes zoster virus from skin or mucosal lesions of patients suspected of infection, and conduct qualitative and typing detection.
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.3305 Seroanalysis of monoperiasis virus
- Import Information
- Input;; QMS/QSD
Dates and status
- Registration Date
- Jul 04, 2023
- Expiry Date
- Jul 04, 2028
About this record
Access comprehensive regulatory information for "Quick" Solana Herpes simplex virus type 1/2 nucleic acid detection reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number dc9d6ca7f8bd872496bebc611d3fa261 and manufactured by QUIDEL CORPORATION. The authorized representative in Taiwan is BIO-CHECK LABORATORIES LTD..
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