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Xpert Xpress Flu/RSV - Taiwan Registration 43b457ee925cb5bda83f6c67b0c63d9d

Access comprehensive regulatory information for Xpert Xpress Flu/RSV in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 43b457ee925cb5bda83f6c67b0c63d9d and manufactured by CEPHEID. The authorized representative in Taiwan is PROGRESSIVE GROUP INC..

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43b457ee925cb5bda83f6c67b0c63d9d
Registration Details
Taiwan FDA Registration: 43b457ee925cb5bda83f6c67b0c63d9d
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Device Details

Xpert Xpress Flu/RSV
TW: ่‰พๆ–ฏๆŸ็‰นๆต่กŒๆ€งๆ„Ÿๅ†’็—…ๆฏ’ๆšจๅ‘ผๅธ้“่žๅˆ็—…ๆฏ’ๅฟซ้€Ÿๆชขๆธฌ่ฉฆๅŠ‘็ต„
Risk Class 2
MD

Registration Details

43b457ee925cb5bda83f6c67b0c63d9d

Ministry of Health Medical Device Import No. 032449

DHA05603244901

Company Information

United States

Product Details

This product is paired with the GeneXpert instrument system for automated multiplex reverse transcription polymerase chain reaction (RT-PCR) assays for in vitro qualitative detection and identification of viral RNA of influenza A, influenza B, and respiratory fusion virus (RSV). This product uses a nasopharynx (NP) and nasal swab (NS) to take specimens from patients suffering from signs and symptoms of respiratory infections. This product combines clinical and epidemiological risk factors for the diagnosis of influenza and respiratory viral infections.

C Immunology and microbiology devices

C3980 Multi-standard nucleic acid test reagent for respiratory viruses

Imported from abroad

Dates and Status

Jun 13, 2019

Jun 13, 2024