Taiwan FDA registration 62d70d2e7d7fd8eaf34d6a4c05120833
"Critical" set of pushgi ST2 protein detection kits
TW: “關鍵”普司吉ST2蛋白檢測試劑組
Taiwan·Risk Class 2·CRITICAL CARE DIAGNOSTICS, INC.;; BIOCHECK, INC.·Registered Sep 11, 2014 – Sep 11, 2019CancelledRegistration details
- Analysis ID
- 62d70d2e7d7fd8eaf34d6a4c05120833
- Customs Code
- DHA05602652607
Company information
- Manufacturer
- CRITICAL CARE DIAGNOSTICS, INC.;; BIOCHECK, INC.
- Manufacturer Country
- United States
- Authorized Representative
- HEALTH ONE NETWORK CO., LTD.
Product details
- Intended Use
- Enzyme-linked immunoassay (ELISA) technology was used to quantitatively detect ST2 protein in human serum or plasma.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1660 Quality control materials (analytical and non-analytical); A.1117 Type B diuretic lithium peptide test system
- Import Information
- Contract manufacturing;; input
Dates and status
- Registration Date
- Sep 11, 2014
- Expiry Date
- Sep 11, 2019
- Cancellation Date
- Jun 22, 2022
Cancellation information
- Status
- Logged out
- Reason
- 許可證已逾有效期
About this record
Access comprehensive regulatory information for "Critical" set of pushgi ST2 protein detection kits in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 62d70d2e7d7fd8eaf34d6a4c05120833 and manufactured by CRITICAL CARE DIAGNOSTICS, INC.;; BIOCHECK, INC.. The authorized representative in Taiwan is HEALTH ONE NETWORK CO., LTD..
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