Taiwan FDA registration b1615df04c5de0e4476934881977fbc5
"Allplex" STI Essential Assay
TW: "奧普列司" 性感染病病原體多標的核酸檢驗試劑套組
Taiwan·Risk Class 2·MD·SEEGENE INC.·Registered Mar 19, 2019 – Mar 19, 2024ExpiredRegistration details
- Analysis ID
- b1615df04c5de0e4476934881977fbc5
- License Form
- Ministry of Health Medical Device Import No. 032377
- Customs Code
- DHA05603237702
Company information
- Manufacturer
- SEEGENE INC.
- Manufacturer Country
- Korea, Republic of
- Authorized Representative
- MEDICARE PRODUCTS INC.
Product details
- Intended Use
- This product is a qualitative in vitro reagent for the detection of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Mycoplasma gonorrhoeae (MG), Mycoplasma urealike (MH), Ureaplasma urealytica (UU), Microureaplasma (UP) and Trichomonas vaginalis (TV) in urine, genital swabs and liquid cytology samples.
- 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
- Mar 19, 2019
- Expiry Date
- Mar 19, 2024
About this record
Access comprehensive regulatory information for "Allplex" STI Essential Assay in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number b1615df04c5de0e4476934881977fbc5 and manufactured by SEEGENE INC.. The authorized representative in Taiwan is MEDICARE PRODUCTS INC..
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