Taiwan FDA registration 331965f2a2fb78dcaf9e971092c61822
Everwin β2 microglobulin immunoassay system
TW: 常盈β2微球蛋白免疫試驗系統
Registration details
- Analysis ID
- 331965f2a2fb78dcaf9e971092c61822
- Customs Code
- DHAS0601635107
Company information
- Manufacturer
- IMMUNOTECH s.r.o.
- Manufacturer Country
- Czechia
- Authorized Representative
- WOLCH ENTERPRISES INC.
Product details
- Intended Use
- 利用放射性體外定量於血清/尿液及血漿中β2-microglobulin可測腎臟相關疾病.
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.5630 β-2-微球蛋白免疫試驗系統
- 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
- Apr 14, 2006
- Expiry Date
- Apr 14, 2016
- Cancellation Date
- Apr 25, 2018
Cancellation information
- Status
- Logged out
- Reason
- 自行鍵入
About this record
Access comprehensive regulatory information for Everwin β2 microglobulin immunoassay system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 331965f2a2fb78dcaf9e971092c61822 and manufactured by IMMUNOTECH s.r.o.. The authorized representative in Taiwan is WOLCH ENTERPRISES INC..
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