Taiwan FDA registration 1e291db5c97f60b88266cd7ebb5b06f8
Immunoassay reagent for alpha-fetoprotein radioimmunoassay
TW: 常盈甲型胎蛋白放射免疫檢驗試劑
Taiwan·Risk Class 2·IMMUNOTECH S.R.O.·Registered May 21, 2010 – May 21, 2015CancelledRegistration details
- Analysis ID
- 1e291db5c97f60b88266cd7ebb5b06f8
- Customs Code
- DHAS0602110703
Company information
- Manufacturer
- IMMUNOTECH S.R.O.
- Manufacturer Country
- Czechia
- Authorized Representative
- WOLCH ENTERPRISES INC.
Product details
- Intended Use
- Extracorporeal radioimmunoassay was used to quantify AFP in serum or amniotic fluid.
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.6010 腫瘤相關抗原免疫試驗系統
- Import Information
- Input;; Consent letter must be attached to the import (consent from the Atomic Energy Commission must be obtained for each import)
Dates and status
- Registration Date
- May 21, 2010
- Expiry Date
- May 21, 2015
- Cancellation Date
- Apr 25, 2018
Cancellation information
- Status
- Logged out
- Reason
- 自行鍵入
About this record
Access comprehensive regulatory information for Immunoassay reagent for alpha-fetoprotein radioimmunoassay in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 1e291db5c97f60b88266cd7ebb5b06f8 and manufactured by IMMUNOTECH S.R.O.. The authorized representative in Taiwan is WOLCH ENTERPRISES INC..
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