Taiwan FDA registration 3025bbb723f9ac022595997bb8aa317a
Elanma procalcitonin test reagent (granular)
TW: 艾濶瑪前降鈣素檢驗試劑(顆粒狀)
Taiwan·Risk Class 2·Boditech Med Inc.·Registered May 24, 2024 – May 24, 2029ActiveRegistration details
- Analysis ID
- 3025bbb723f9ac022595997bb8aa317a
- Customs Code
- DHA05603708106
Company information
- Manufacturer
- Boditech Med Inc.
- Manufacturer Country
- Korea, Republic of
- Authorized Representative
- MEDRICH INSTRUMENT CO., LTD.
Product details
- Intended Use
- This product is a fluorescent immunoassay (FIA) for the quantitative determination of procalcitonin in human whole blood/serum/plasma. It helps to aid in the diagnosis, management, and monitoring of people with bacterial infections and sepsis.
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.3210 內毒素分析試劑
- Import Information
- Input;; QMS/QSD
Dates and status
- Registration Date
- May 24, 2024
- Expiry Date
- May 24, 2029
About this record
Access comprehensive regulatory information for Elanma procalcitonin test reagent (granular) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 3025bbb723f9ac022595997bb8aa317a and manufactured by Boditech Med Inc.. The authorized representative in Taiwan is MEDRICH INSTRUMENT CO., LTD..
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