Taiwan FDA registration 039ac4dbce158ef23ac2e2c08d429d32
"Speedi" Chlamydomys antigen rapid test reagent (unsterilized)
TW: “速帝”披衣菌抗原快速檢驗試劑(未滅菌)
Taiwan·Risk Class 1·STANDARD DIAGNOSTICS, INC.·Registered Aug 12, 2010 – Aug 12, 2020CancelledRegistration details
- Analysis ID
- 039ac4dbce158ef23ac2e2c08d429d32
- Customs Code
- DHA04400909102
Company information
- Manufacturer
- STANDARD DIAGNOSTICS, INC.
- Manufacturer Country
- Korea, Republic of
- Authorized Representative
- Abbott Rapid Diagnostics Health Corp.
Product details
- Intended Use
- Limited to the first grade identification range of Chlamydomydia serological reagent (C.3120) for the management of medical devices.
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.3120 披衣菌血清試劑
- Import Information
- import
Dates and status
- Registration Date
- Aug 12, 2010
- Expiry Date
- Aug 12, 2020
- Cancellation Date
- Jul 15, 2022
Cancellation information
- Status
- Logged out
- Reason
- 未展延而逾期者
About this record
Access comprehensive regulatory information for "Speedi" Chlamydomys antigen rapid test reagent (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 039ac4dbce158ef23ac2e2c08d429d32 and manufactured by STANDARD DIAGNOSTICS, INC.. The authorized representative in Taiwan is Abbott Rapid Diagnostics Health Corp..
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