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"Aikuailu" Adenovirus and Respiratory Fusion Cell Virus Rapid Test Reagent (Unsterilized) - Taiwan Registration b9cd20c4920f65b374da5dd80fcd3452

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..

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.

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b9cd20c4920f65b374da5dd80fcd3452
Registration Details
Taiwan FDA Registration: b9cd20c4920f65b374da5dd80fcd3452
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Device Details

"Aikuailu" Adenovirus and Respiratory Fusion Cell Virus Rapid Test Reagent (Unsterilized)
TW: "่‰พๅฟซ้œฒ" ่…บ็—…ๆฏ’ๅŠๅ‘ผๅธ้“่žๅˆ็ดฐ่ƒž็—…ๆฏ’ๅฟซ้€Ÿๆชข้ฉ—่ฉฆๅŠ‘(ๆœชๆป…่Œ)
Risk Class 1

Registration Details

b9cd20c4920f65b374da5dd80fcd3452

DHA09401911107

Company Information

United States

Product Details

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.

C Immunology and microbiology

C.3480 ๅ‘ผๅธ้“่žๅˆ็ดฐ่ƒž็—…ๆฏ’่ก€ๆธ…่ฉฆๅŠ‘;; C.3020 ่…บ็—…ๆฏ’่ก€ๆธ…่ฉฆๅŠ‘

QMS/QSD;; ่ผธๅ…ฅ

Dates and Status

May 29, 2018

May 29, 2028