Taiwan FDA registration 5ec4b2ac2e400545d356b9ccf8070de6
RAMP CK-MB Assay
TW: 倫普肌酸磷酸激酶MB同功酶檢驗試劑組
Taiwan·Risk Class 2·MD·RESPONSE BIOMEDICAL CORPORATION·Registered Dec 02, 2015 – Dec 02, 2025ExpiredRegistration details
- Analysis ID
- 5ec4b2ac2e400545d356b9ccf8070de6
- License Form
- Ministry of Health Medical Device Import No. 027925
- Customs Code
- DHA05602792500
Company information
- Manufacturer
- RESPONSE BIOMEDICAL CORPORATION
- Manufacturer Country
- Canada
- Authorized Representative
- RECHI CO., LTD.
Product details
- Intended Use
- This product is a quantitative immunochromolayer analysis method, which is an in vitro diagnostic product for detecting CK-MB concentration in EDTA whole blood, and needs to be used with RAMP Reader System or RAMP 200 System.
- 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
- Dec 02, 2015
- Expiry Date
- Dec 02, 2025
About this record
Access comprehensive regulatory information for RAMP CK-MB Assay in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 5ec4b2ac2e400545d356b9ccf8070de6 and manufactured by RESPONSE BIOMEDICAL CORPORATION. The authorized representative in Taiwan is RECHI CO., LTD..
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