Taiwan FDA registration 5290a5364e03c4d15fae01cb16032256
Immunoassay kit for the enzyme specific antigen of the universal prostate
TW: 普生前列腺特異性抗原酵素免疫分析套組
Registration details
- Analysis ID
- 5290a5364e03c4d15fae01cb16032256
- Customs Code
- DHA00601784503
Company information
- Manufacturer
- BIOCHECK, INC.
- Manufacturer Country
- United States
- Authorized Representative
- GENERAL BIOLOGICALS CORP.
Product details
- Intended Use
- The concentration of human serum tumor antigen PSA was quantitatively detected.
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.6010 腫瘤相關抗原免疫試驗系統
- Import Information
- import
Dates and status
- Registration Date
- Dec 20, 2006
- Expiry Date
- Dec 20, 2016
- Cancellation Date
- Jun 28, 2018
Cancellation information
- Status
- Logged out
- Reason
- 許可證已逾有效期
About this record
Access comprehensive regulatory information for Immunoassay kit for the enzyme specific antigen of the universal prostate in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 5290a5364e03c4d15fae01cb16032256 and manufactured by BIOCHECK, INC.. The authorized representative in Taiwan is GENERAL BIOLOGICALS CORP..
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