Taiwan FDA registration 34e0ac0d2161546c5dcb96dba40cf90b
Elunma procalcitonin test reagent
TW: 艾濶瑪前降鈣素檢驗試劑
Taiwan·Risk Class 2·Boditech Med Inc.·Registered Dec 07, 2022 – Dec 07, 2027ActiveRegistration details
- Analysis ID
- 34e0ac0d2161546c5dcb96dba40cf90b
- Customs Code
- DHA05603589105
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.
- Product Type (Level 1)
- A Clinical Chemistry and Clinical Toxicology;; C Immunology and Microbiology
- Product Type (Level 2)
- C.3210 Endotoxin Analysis Test;; A.1660 Quality control materials (analytical and non-analytical)
- Import Information
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Dec 07, 2022
- Expiry Date
- Dec 07, 2027
About this record
Access comprehensive regulatory information for Elunma procalcitonin test reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 34e0ac0d2161546c5dcb96dba40cf90b and manufactured by Boditech Med Inc.. The authorized representative in Taiwan is MEDRICH INSTRUMENT CO., LTD..
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