Taiwan FDA registration fabe7b06eb8b0bed119f194134be2f02
"Oplis" mycoplasma azithromycin resistance multi-standard nucleic acid test reagent set
TW: "奧普列司"黴漿菌阿奇黴素抗藥性多標的核酸檢驗試劑套組
Taiwan·Risk Class 2·SEEGENE INC.·Registered Jan 19, 2022 – Jan 19, 2027ActiveRegistration details
- Analysis ID
- fabe7b06eb8b0bed119f194134be2f02
- Customs Code
- DHA05603520705
Company information
- Manufacturer
- SEEGENE INC.
- Manufacturer Country
- Korea, Republic of
- Authorized Representative
- MEDICARE PRODUCTS INC.
Product details
- Intended Use
- This product is Real-Time PCR, which is used to detect mutations in A2058G, A2058C, A2058T, A2059G, A2059C and A2059T of Mycoplasma genitalis located in the 23S rRNA gene that is resistant to azithromycin.
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.1640 抗菌感受性試驗粉末
- Import Information
- Input;; QMS/QSD
Dates and status
- Registration Date
- Jan 19, 2022
- Expiry Date
- Jan 19, 2027
About this record
Access comprehensive regulatory information for "Oplis" mycoplasma azithromycin resistance multi-standard nucleic acid test reagent set in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number fabe7b06eb8b0bed119f194134be2f02 and manufactured by SEEGENE INC.. The authorized representative in Taiwan is MEDICARE PRODUCTS INC..
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