Taiwan FDA registration e794d665f4cf27d33645e927d86e9dff
Quidel Lyra Direct C.difficile Assay
TW: 快得利萊拉困難梭狀芽孢桿菌分子檢測試劑
Taiwan·Risk Class 2·MD·QUIDEL CORPORATION·Registered Apr 14, 2018 – Apr 14, 2023ExpiredRegistration details
- Analysis ID
- e794d665f4cf27d33645e927d86e9dff
- License Form
- Ministry of Health Medical Device Import No. 030538
- Customs Code
- DHA05603053803
Company information
- Manufacturer
- QUIDEL CORPORATION
- Manufacturer Country
- United States
- Authorized Representative
- BIO-CHECK LABORATORIES LTD.
Product details
- Intended Use
- This product was tested as a multi-standard quantitative detection reagent, which showed the toxin A gene (tcdA) and toxin B gene (tcdB) of Clostridium difficile to assist in the diagnosis of Clostridium difficile related diseases (CDAD).
- Product Type (Level 1)
- C Immunology and microbiology devices
- Product Type (Level 2)
- C3130 困難梭狀桿菌毒素(ClostridiumDifficileToxin)基因擴增試劑
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Apr 14, 2018
- Expiry Date
- Apr 14, 2023
About this record
Access comprehensive regulatory information for Quidel Lyra Direct C.difficile Assay in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number e794d665f4cf27d33645e927d86e9dff and manufactured by QUIDEL CORPORATION. The authorized representative in Taiwan is BIO-CHECK LABORATORIES LTD..
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