Taiwan FDA registration 4802d1da810b2785534059040738aac2

"Aikuailu" adenovirus/respiratory fusion cell virus/influenza A+B rapid test reagent (unsterilized)

TW: “艾快露”腺病毒/呼吸道融合細胞病毒/A+B型流行性感冒快速檢測試劑 (未滅菌)

Taiwan·Risk Class 1·ACRO BIOTECH. INC.·Registered Apr 08, 2019 – Apr 08, 2024Expired

Registration details

Analysis ID: 4802d1da810b2785534059040738aac2
Customs Code: DHA09402027501

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 of identification of "adenovirus serum reagent (C.3020)", "respiratory fusion cell virus serum reagent (C.3480)" and "influenza virus serum reagent (C.3330)" of the management measures for the classification and grading of 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.3330 流感病毒血清試劑;; C.3020 腺病毒血清試劑
Import Information: import

Dates and status

Registration Date: Apr 08, 2019
Expiry Date: Apr 08, 2024

About this record

Access comprehensive regulatory information for "Aikuailu" adenovirus/respiratory fusion cell virus/influenza A+B 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 4802d1da810b2785534059040738aac2 and manufactured by ACRO BIOTECH. INC.. The authorized representative in Taiwan is Grand Marquis IVD CO., LTD..

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