Taiwan FDA registration 43b457ee925cb5bda83f6c67b0c63d9d

Xpert Xpress Flu/RSV

TW: 艾斯柏特流行性感冒病毒暨呼吸道融合病毒快速檢測試劑組

Taiwan·Risk Class 2·MD·CEPHEID·Registered Jun 13, 2019 – Jun 13, 2024Expired

Registration details

Analysis ID: 43b457ee925cb5bda83f6c67b0c63d9d
License Form: Ministry of Health Medical Device Import No. 032449
Customs Code: DHA05603244901

Company information

Manufacturer: CEPHEID
Manufacturer Country: United States
Authorized Representative: PROGRESSIVE GROUP INC.

Product details

Intended Use: 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.
Product Type (Level 1): C Immunology and microbiology devices
Product Type (Level 2): C3980 Multi-standard nucleic acid test reagent for respiratory viruses
Import Information: Imported from abroad

Dates and status

Registration Date: Jun 13, 2019
Expiry Date: Jun 13, 2024

About this record

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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