Taiwan FDA registration d83cfbd4622cd3b078123ebf4e840697
Omega Syphilis IGM immunoglobulin reagent
TW: 奧米加梅毒IGM免疫球蛋白試劑
Registration details
- Analysis ID
- d83cfbd4622cd3b078123ebf4e840697
- Customs Code
- DHA00601638707
Company information
- Manufacturer
- OMEGA DIAGNOSTICS LTD.
- Manufacturer Country
- United Kingdom
- Authorized Representative
- EUGENE-CHEN CO., LTD.
Product details
- Intended Use
- Enzyme immunoassay was used to detect treponemal IgM antibodies in human serum.
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.3830 Treponema pallidum test
- Import Information
- import
Dates and status
- Registration Date
- Apr 19, 2006
- Expiry Date
- Apr 19, 2016
- Cancellation Date
- Jun 25, 2018
Cancellation information
- Status
- Logged out
- Reason
- 許可證已逾有效期
About this record
Access comprehensive regulatory information for Omega Syphilis IGM immunoglobulin reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number d83cfbd4622cd3b078123ebf4e840697 and manufactured by OMEGA DIAGNOSTICS LTD.. The authorized representative in Taiwan is EUGENE-CHEN CO., LTD..
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