Taiwan FDA registration 4d869e9b52071fddddd46567cc02012d
"Ecolo" A+B influenza rapid test reagent
TW: "愛可羅"A+B 型流行性感冒快速檢驗試劑
Taiwan·Risk Class 2·ACRO BIOTECH. INC.·Registered Sep 30, 2022 – Sep 30, 2027ActiveRegistration details
- Analysis ID
- 4d869e9b52071fddddd46567cc02012d
- Customs Code
- DHA05603585705
Company information
- Manufacturer
- ACRO BIOTECH. INC.
- Manufacturer Country
- United States
- Authorized Representative
- APPLIED BIOTECH ENTERPRISE CO., LTD.
Product details
- Intended Use
- This product uses rapid immunochromatography to qualitatively detect and distinguish influenza A and B virus antigens in human nasopharyngeal swabs.
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.3328 Influenza Virus Antigen Rapid Screening and Detection System
- Import Information
- Input;; QMS/QSD
Dates and status
- Registration Date
- Sep 30, 2022
- Expiry Date
- Sep 30, 2027
About this record
Access comprehensive regulatory information for "Ecolo" A+B influenza rapid test reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 4d869e9b52071fddddd46567cc02012d and manufactured by ACRO BIOTECH. INC.. The authorized representative in Taiwan is APPLIED BIOTECH ENTERPRISE CO., LTD..
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