Taiwan FDA registration c7b391f7e91924240af110be4fbe0904
"Nanotek" Nano Chuck Myocardial Infarction Rapid Test Set
TW: "奈米鐵克" 奈米查克心肌梗塞快速檢測試劑組
Taiwan·Risk Class 2·Nano-Ditech Corporation·Registered Apr 13, 2021 – Apr 13, 2026ExpiredRegistration details
- Analysis ID
- c7b391f7e91924240af110be4fbe0904
- Customs Code
- DHA05603438501
Company information
- Manufacturer
- Nano-Ditech Corporation
- Manufacturer Country
- United States
- Authorized Representative
- GRAND MARQUIS CO., LTD.
Product details
- Intended Use
- This product uses immunochromocytometry to determine the concentration of troponin I, creatine kinase and myoglobin in human whole blood, serum and plasma samples.
- Product Type (Level 1)
- A Clinical Chemistry and Clinical Toxicology;; C Immunology and Microbiology
- Product Type (Level 2)
- A.1215 Creatine phosphokinase/creatine kinase or isoenzyme testing system; C.5680 Myoglobin immunoassay system
- Import Information
- Input;; QMS/QSD
Dates and status
- Registration Date
- Apr 13, 2021
- Expiry Date
- Apr 13, 2026
About this record
Access comprehensive regulatory information for "Nanotek" Nano Chuck Myocardial Infarction Rapid Test Set in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number c7b391f7e91924240af110be4fbe0904 and manufactured by Nano-Ditech Corporation. The authorized representative in Taiwan is GRAND MARQUIS CO., LTD..
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