Taiwan FDA registration 594adc7226cbfca1bc1847d5c54a4d9a
Billman Calprotectin immunoturbidimetry reagent set
TW: 必爾曼鈣衛蛋白免疫比濁法試劑組
Registration details
- Analysis ID
- 594adc7226cbfca1bc1847d5c54a4d9a
- Customs Code
- DHA05603368709
Company information
- Manufacturer
- BÜHLMANN LABORATORIES AG
- Manufacturer Country
- Switzerland
- Authorized Representative
- Siloam Biotech Co., Ltd.
Product details
- Intended Use
- This product is an automated in vitro diagnostic test for the quantitative detection of calprotectin content in human fecal samples to assess intestinal mucosal inflammation.
- Product Type (Level 1)
- A Clinical Chemistry and Clinical Toxicology;; C Immunology and Microbiology
- Product Type (Level 2)
- C.5180 Fecal Calcium Protein Immunoassay System;; A.1660 Quality control materials (analytical and non-analytical); A.1150 calibration
- Import Information
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- Oct 19, 2020
- Expiry Date
- Oct 19, 2025
About this record
Access comprehensive regulatory information for Billman Calprotectin immunoturbidimetry reagent set in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 594adc7226cbfca1bc1847d5c54a4d9a and manufactured by BÜHLMANN LABORATORIES AG. The authorized representative in Taiwan is Siloam Biotech Co., Ltd..
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