Taiwan FDA registration 8ef4483a731f060ee2478fd3ae77368d
"Ai Kuailu" B Streptococcus Rapid Test Reagent (Unsterilized)
TW: "艾快露" B群鏈球菌快速檢驗試劑 (未滅菌)
Registration details
- Analysis ID
- 8ef4483a731f060ee2478fd3ae77368d
- Customs Code
- DHA09401710209
Company information
- Manufacturer
- ACRO BIOTECH. INC.
- Manufacturer Country
- United States
- Authorized Representative
- Grand Marquis IVD CO., LTD.
Product details
- Intended Use
- Classification and grading management method of medical equipment: Streptococcus belongs to the first level identification range of serum reagent (C.3740).
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.3740 鏈球菌屬血清試劑
- Import Information
- import
Dates and status
- Registration Date
- Oct 20, 2016
- Expiry Date
- Oct 20, 2026
About this record
Access comprehensive regulatory information for "Ai Kuailu" B Streptococcus Rapid Test Reagent (Unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 8ef4483a731f060ee2478fd3ae77368d and manufactured by ACRO BIOTECH. INC.. The authorized representative in Taiwan is Grand Marquis IVD CO., LTD..
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