Taiwan FDA registration e2cae031db66436c493b7652e5233463
Nanobia fibrinogen protein decomposition assay reagent
TW: 納諾比亞纖維蛋白原蛋白分解物測定試劑
Registration details
- Analysis ID
- e2cae031db66436c493b7652e5233463
- Customs Code
- DHA00602469004
Company information
- Manufacturer
- SEKISUI MEDICAL CO., LTD. TSUKUBA PLANT
- Manufacturer Country
- Japan
- Authorized Representative
- KUO'S YUAN IN ENTERPRISE CO., LTD.
Product details
- Intended Use
- Detect fibrous protein degradants (FDPs) in blood or serum.
- Product Type (Level 1)
- B Haematology, pathology and genetics; A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1660 Quality control materials (analytical and non-analytical); A.1150 calibration;; B.7320 Analysis of pro-fiber/fiber-based protein disintegration products
- Import Information
- import
Dates and status
- Registration Date
- May 20, 2013
- Expiry Date
- May 20, 2018
- Cancellation Date
- Nov 04, 2019
Cancellation information
- Status
- Logged out
- Reason
- 未展延而逾期者
About this record
Access comprehensive regulatory information for Nanobia fibrinogen protein decomposition assay reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number e2cae031db66436c493b7652e5233463 and manufactured by SEKISUI MEDICAL CO., LTD. TSUKUBA PLANT. The authorized representative in Taiwan is KUO'S YUAN IN ENTERPRISE CO., LTD..
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