Taiwan FDA registration 75965af8c1520ec1a98127ebb436ac32
Firstep Streptococcus pneumoniae Antigen Rapid Test (Non-Sterile)
TW: 聯華肺炎鏈球菌抗原檢測試劑(未滅菌)
Registration details
- Analysis ID
- 75965af8c1520ec1a98127ebb436ac32
- License Form
- Ministry of Health Medical Device Manufacturing No. 007251
Company information
- Manufacturer
- FIRSTEP BIORESEARCH INC.
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- FIRSTEP BIORESEARCH INC.
Product details
- Intended Use
- Restriction of medical device management methods Streptococcus belongs to the first level identification range of serum reagent (C.3740).
- Product Type (Level 1)
- C Immunology and microbiology devices
- Product Type (Level 2)
- C3740 Streptococcus serology
- Import Information
- Produced in Taiwan, China
Dates and status
- Registration Date
- May 14, 2018
- Expiry Date
- May 14, 2023
About this record
Access comprehensive regulatory information for Firstep Streptococcus pneumoniae Antigen Rapid Test (Non-Sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 75965af8c1520ec1a98127ebb436ac32 and manufactured by FIRSTEP BIORESEARCH INC.. The authorized representative in Taiwan is FIRSTEP BIORESEARCH INC..
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