Taiwan FDA registration 8c2d5633df263ec2aa7930127bd3898d
"Dirk" Bacteryloribacter pylori antigen enzyme immunoassay
TW: "德克" 幽門桿菌抗原酵素免疫試劑
Registration details
- Analysis ID
- 8c2d5633df263ec2aa7930127bd3898d
- Customs Code
- DHY04300170901
Company information
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- Dirk International Limited
Product details
- Intended Use
- Limited to the first level identification range of the Measures for the Administration of Medical Devices "Helicobacter Serological Reagent (C.0003)".
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.0003 螺旋桿菌屬血清試劑
- Import Information
- Contract manufacturing;; Domestic
Dates and status
- Registration Date
- Nov 21, 2006
- Expiry Date
- Nov 21, 2011
- Cancellation Date
- Nov 16, 2012
Cancellation information
- Status
- Logged out
- Reason
- 許可證已逾有效期
About this record
Access comprehensive regulatory information for "Dirk" Bacteryloribacter pylori antigen enzyme immunoassay in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 8c2d5633df263ec2aa7930127bd3898d and manufactured by Baoling Fujin Biotechnology Co., Ltd. Medical Equipment Factory. The authorized representative in Taiwan is Dirk International Limited.
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