Taiwan FDA registration f2cc8fb7d5269de8c38624ff80764275

"Aikuailu" Rotavirus/Adenovirus 2-in-1 Rapid Test Reagent (Unsterilized)

TW: "艾快露" 輪狀病毒/腺病毒二合一快速檢測試劑 (未滅菌)

Taiwan·Risk Class 1·ACRO BIOTECH INC.·Registered Nov 25, 2016 – Nov 25, 2026Active

Registration details

Analysis ID: f2cc8fb7d5269de8c38624ff80764275
Customs Code: DHA09401721407

Company information

Manufacturer: ACRO BIOTECH INC.
Manufacturer Country: United States
Authorized Representative: Grand Marquis IVD CO., LTD.

Product details

Intended Use: It is limited to the first-level identification scope of the "Adenovirus Serum Reagent (C.3020)" and "Poliovirus Serum Reagent (C.3405)" of the Classification and Grading Management Measures for Medical Devices.
Product Type (Level 1): C Immunology and microbiology
Product Type (Level 2): C.3020 腺病毒血清試劑;; C.3405 小兒麻痺病毒血清試劑
Import Information: Input;; QMS/QSD

Dates and status

Registration Date: Nov 25, 2016
Expiry Date: Nov 25, 2026

About this record

Access comprehensive regulatory information for "Aikuailu" Rotavirus/Adenovirus 2-in-1 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 f2cc8fb7d5269de8c38624ff80764275 and manufactured by ACRO BIOTECH INC.. The authorized representative in Taiwan is Grand Marquis IVD CO., LTD..

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