Taiwan FDA registration ae13acbdea712b4ff39a12dd9375e507
"Speedi" Para-Legionella antigen rapid diagnostic reagent (unsterilized)
TW: "速帝" 百而靈 退伍軍人桿菌抗原快速診斷試劑 (未滅菌)
Taiwan·Risk Class 1·STANDARD DIAGNOSTICS, INC.·Registered Jun 20, 2011 – Jun 20, 2021CancelledRegistration details
- Analysis ID
- ae13acbdea712b4ff39a12dd9375e507
- Customs Code
- DHA04401048803
Company information
- Manufacturer
- STANDARD DIAGNOSTICS, INC.
- Manufacturer Country
- Korea, Republic of
- Authorized Representative
- Abbott Rapid Diagnostics Health Corp.
Product details
- Intended Use
- Limit the management method of medical equipment Haemophilus serogenus (C.3300) first level identification range.
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.3300 嗜血桿菌屬血清試劑
- Import Information
- import
Dates and status
- Registration Date
- Jun 20, 2011
- Expiry Date
- Jun 20, 2021
- Cancellation Date
- Oct 12, 2023
Cancellation information
- Status
- Logged out
- Reason
- 未展延而逾期者
About this record
Access comprehensive regulatory information for "Speedi" Para-Legionella antigen rapid diagnostic 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 ae13acbdea712b4ff39a12dd9375e507 and manufactured by STANDARD DIAGNOSTICS, INC.. The authorized representative in Taiwan is Abbott Rapid Diagnostics Health Corp..
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