Taiwan FDA registration 93af533a3f12da25218632b5fa6da356
Cutting-edge medical kaitamine (K tamin) rapid test reagent
TW: 尖端醫 愷他命(K他命)快速檢驗試劑
Taiwan·Risk Class 2·Formosa Biomedical Technology Co., Ltd. Yilan Factory·Registered Nov 16, 2018 – Jun 20, 2028ActiveRegistration details
- Analysis ID
- 93af533a3f12da25218632b5fa6da356
Company information
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- TAIWAN ADVANCE BIO-PHARMACEUTICAL INC.
Product details
- Intended Use
- This product uses competitive immunochromatography to qualitatively detect katamine in human urine. The test results can be used for initial screening. The threshold standard for katamine is set at 100 ng/ml. This product can be used by both individuals and professionals.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.0001 苯環利定試驗系統
- Import Information
- Domestic;; Contract manufacturing
Dates and status
- Registration Date
- Nov 16, 2018
- Expiry Date
- Jun 20, 2028
About this record
Access comprehensive regulatory information for Cutting-edge medical kaitamine (K tamin) rapid test reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 93af533a3f12da25218632b5fa6da356 and manufactured by Formosa Biomedical Technology Co., Ltd. Yilan Factory. The authorized representative in Taiwan is TAIWAN ADVANCE BIO-PHARMACEUTICAL INC..
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