Taiwan FDA registration b9cd20c4920f65b374da5dd80fcd3452

"Aikuailu" Adenovirus and Respiratory Fusion Cell Virus Rapid Test Reagent (Unsterilized)

TW: "艾快露" 腺病毒及呼吸道融合細胞病毒快速檢驗試劑(未滅菌)

Taiwan·Risk Class 1·ACRO BIOTECH INC.·Registered May 29, 2018 – May 29, 2028Active

Registration details

Analysis ID: b9cd20c4920f65b374da5dd80fcd3452
Customs Code: DHA09401911107

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 "Respiratory Fusion Cell Virus Serum Reagent (C.3480)" in the Classification and Grading Management Measures for Medical Devices.
Product Type (Level 1): C Immunology and microbiology
Product Type (Level 2): C.3480 呼吸道融合細胞病毒血清試劑;; C.3020 腺病毒血清試劑
Import Information: QMS/QSD;; 輸入

Dates and status

Registration Date: May 29, 2018
Expiry Date: May 29, 2028

About this record

Access comprehensive regulatory information for "Aikuailu" Adenovirus and Respiratory Fusion Cell Virus 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 b9cd20c4920f65b374da5dd80fcd3452 and manufactured by ACRO BIOTECH INC.. The authorized representative in Taiwan is Grand Marquis IVD CO., LTD..

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