Taiwan FDA registration b3eca6e5d3c81e0f76640c18e5e0844d
"AMERITEK" Strep A Rapid Test (Non-Sterile)
TW: "爾美力特"A型鏈球菌試劑(未滅菌)
Registration details
- Analysis ID
- b3eca6e5d3c81e0f76640c18e5e0844d
- License Form
- Ministry of Health Medical Device Import No. 013807
- Customs Code
- DHA09401380701
Company information
- Manufacturer
- AMERITEK, INC.
- Manufacturer Country
- United States
- Authorized Representative
- APPLIED BIOTECH ENTERPRISE CO., LTD.
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
- Jan 23, 2014
- Expiry Date
- Jan 23, 2024
About this record
Access comprehensive regulatory information for "AMERITEK" Strep A 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 b3eca6e5d3c81e0f76640c18e5e0844d and manufactured by AMERITEK, INC.. The authorized representative in Taiwan is APPLIED BIOTECH ENTERPRISE CO., LTD..
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