Taiwan FDA registration ef864ce315717b0d863f33812db293da
"Trinity" Streptococcus Pneumoniae Kit (non-sterile)
TW: "萃尼諦" 肺炎鏈球菌檢驗試劑組 (未滅菌)
Registration details
- Analysis ID
- ef864ce315717b0d863f33812db293da
- License Form
- Ministry of Health Medical Device Import No. 013650
- Customs Code
- DHA09401365007
Company information
- Manufacturer
- TRINITY BIOTECH USA
- Manufacturer Country
- United States
- Authorized Representative
- TRUGENE DIAGNOSTICS, 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
- Imported from abroad
Dates and status
- Registration Date
- Dec 02, 2013
- Expiry Date
- Dec 02, 2023
About this record
Access comprehensive regulatory information for "Trinity" Streptococcus Pneumoniae Kit (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 ef864ce315717b0d863f33812db293da and manufactured by TRINITY BIOTECH USA. The authorized representative in Taiwan is TRUGENE DIAGNOSTICS, INC..
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