Taiwan FDA registration 2150f0ea7c15232ec4e878600c7df071
RAMP TroponinⅠAssay
TW: “倫普” 肌鈣蛋白Ⅰ檢驗試劑組
Registration details
- Analysis ID
- 2150f0ea7c15232ec4e878600c7df071
- License Form
- Ministry of Health Medical Device Import No. 027892
- Customs Code
- DHA05602789201
Company information
- Manufacturer
- RESPONSE BIOMEDICAL CORPORATION
- Manufacturer Country
- Canada
- Authorized Representative
- RECHI CO., LTD.
Product details
- Intended Use
- This product is an in vitro diagnostic product used in combination with RAMP Reader System or RAMP 200 system using quantitative immunochromatography, used to detect Troponin І concentration in EDTA whole blood.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A1215 Creatine phosphocatalyzed?/creatine excitation or isomeric test system
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Nov 02, 2015
- Expiry Date
- Nov 02, 2025
About this record
Access comprehensive regulatory information for RAMP TroponinⅠAssay in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 2150f0ea7c15232ec4e878600c7df071 and manufactured by RESPONSE BIOMEDICAL CORPORATION. The authorized representative in Taiwan is RECHI CO., LTD..
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