Taiwan FDA registration 6d46f7c9715945d3eba56c6e6169d57b

AsiaGen Dengue NS1 Antigen Rapid Test Kit

TW: 亞洲基因登革熱NS1抗原快速檢驗試劑

Taiwan·Risk Class 2·MD·Asia Genomics Technology Co., Ltd. Factory 1·Registered May 01, 2017 – May 01, 2027Active

Registration details

Analysis ID: 6d46f7c9715945d3eba56c6e6169d57b
License Form: Ministry of Health Medical Device Manufacturing No. 005613

Company information

Manufacturer: Asia Genomics Technology Co., Ltd. Factory 1
Manufacturer Country: Taiwan, Province of China
Authorized Representative: Asia Genomics Technology Co., Ltd. Factory 1

Product details

Intended Use: Non-structural protein 1 (NS1) of dengue virus in whole blood, serum or plasma by chromocytometry
Product Type (Level 1): C Immunology and microbiology devices
Product Type (Level 2): C0002 Dengue virus serum reagent
Import Information: Produced in Taiwan, China

Dates and status

Registration Date: May 01, 2017
Expiry Date: May 01, 2027

About this record

Access comprehensive regulatory information for AsiaGen Dengue NS1 Antigen Rapid Test Kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 6d46f7c9715945d3eba56c6e6169d57b and manufactured by Asia Genomics Technology Co., Ltd. Factory 1. The authorized representative in Taiwan is Asia Genomics Technology Co., Ltd. Factory 1.

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