Taiwan FDA registration faf65952ee653064180b08e786be3c8f
"Allplex" Candidiasis Assay
TW: "奧普列司" 念珠菌症多標的核酸檢驗試劑套組
Taiwan·Risk Class 2·MD·SEEGENE INC.·Registered Jan 22, 2019 – Jan 22, 2024ExpiredRegistration details
- Analysis ID
- faf65952ee653064180b08e786be3c8f
- License Form
- Ministry of Health Medical Device Import No. 032129
- Customs Code
- DHA05603212909
Company information
- Manufacturer
- SEEGENE INC.
- Manufacturer Country
- Korea, Republic of
- Authorized Representative
- MEDICARE PRODUCTS INC.
Product details
- Intended Use
- This product is used for qualitative in vitro tests to detect Candida albicans albicans (CA), Candida cruz (CK), Candida glabrum (CG), Candida dublin (CD), Candida near smoothing (CP), Candida tropicalis (CTp) and Candida Portugal (CL) in urine, genital swabs and liquid cytology specimens.
- Product Type (Level 1)
- C Immunology and microbiology devices
- Product Type (Level 2)
- C9999 Other
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Jan 22, 2019
- Expiry Date
- Jan 22, 2024
About this record
Access comprehensive regulatory information for "Allplex" Candidiasis Assay in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number faf65952ee653064180b08e786be3c8f and manufactured by SEEGENE INC.. The authorized representative in Taiwan is MEDICARE PRODUCTS INC..
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