Taiwan FDA registration 4c016dc1bc955827a644ac9ab3f54529
KatiaTM ENA Outline Assay Set
TW: 卡蒂雅TM ENA概要檢測試劑組
Taiwan·Risk Class 2·TRINITY BIOTECH USA·Registered Aug 10, 2006 – Aug 10, 2011CancelledRegistration details
- Analysis ID
- 4c016dc1bc955827a644ac9ab3f54529
- Customs Code
- DHA00601727004
Company information
- Manufacturer
- TRINITY BIOTECH USA
- Manufacturer Country
- United States
- Authorized Representative
- GRAND MARQUIS CO., LTD.
Product details
- Intended Use
- Enzyme immunosorption analysis was used to detect ENA antigen in human serum.
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.5100 抗核抗體免疫試驗系統
- Import Information
- import
Dates and status
- Registration Date
- Aug 10, 2006
- Expiry Date
- Aug 10, 2011
- Cancellation Date
- Nov 27, 2012
Cancellation information
- Status
- Logged out
- Reason
- 許可證已逾有效期
About this record
Access comprehensive regulatory information for KatiaTM ENA Outline Assay Set in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 4c016dc1bc955827a644ac9ab3f54529 and manufactured by TRINITY BIOTECH USA. The authorized representative in Taiwan is GRAND MARQUIS CO., LTD..
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