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"Oplis" mycoplasma azithromycin resistance multi-standard nucleic acid test reagent set - Taiwan Registration fabe7b06eb8b0bed119f194134be2f02

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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Registration Details
Taiwan FDA Registration: fabe7b06eb8b0bed119f194134be2f02
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Device Details

"Oplis" mycoplasma azithromycin resistance multi-standard nucleic acid test reagent set
TW: "ๅฅงๆ™ฎๅˆ—ๅธ"้ปดๆผฟ่Œ้˜ฟๅฅ‡้ปด็ด ๆŠ—่—ฅๆ€งๅคšๆจ™็š„ๆ ธ้…ธๆชข้ฉ—่ฉฆๅŠ‘ๅฅ—็ต„
Risk Class 2

Registration Details

fabe7b06eb8b0bed119f194134be2f02

DHA05603520705

Company Information

Korea, Republic of

Product Details

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.

C Immunology and microbiology

C.1640 ๆŠ—่Œๆ„Ÿๅ—ๆ€ง่ฉฆ้ฉ—็ฒ‰ๆœซ

Input;; QMS/QSD

Dates and Status

Jan 19, 2022

Jan 19, 2027