Taiwan FDA registration 125fbd8d808bb2f8ccfad1ae9965dddb
Buhlmann fCAL ELISA
TW: 必爾曼鈣衛蛋白酵素免疫分析試劑組
Registration details
- Analysis ID
- 125fbd8d808bb2f8ccfad1ae9965dddb
- License Form
- Ministry of Health Medical Device Import No. 031992
- Customs Code
- DHA05603199204
Company information
- Manufacturer
- BUHLMANN LABORATORIES AG
- Manufacturer Country
- Switzerland
- Authorized Representative
- Siloam Biotech Co., Ltd.
Product details
- Intended Use
- This product is an in vitro diagnostic reagent for the quantitative detection of calprotectin in human feces to assess gastrointestinal mucosal inflammation.
- Product Type (Level 1)
- C Immunology and microbiology devices
- Product Type (Level 2)
- C5180 Fecal calprotectin immunoassay system
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Dec 26, 2018
- Expiry Date
- Dec 26, 2023
About this record
Access comprehensive regulatory information for Buhlmann fCAL ELISA in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 125fbd8d808bb2f8ccfad1ae9965dddb and manufactured by BUHLMANN LABORATORIES AG. The authorized representative in Taiwan is Siloam Biotech Co., Ltd..
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