Taiwan FDA registration d1dd1d6a00f7f328d6f6eb061d0a56f6

Roche Cobas influenza A/B/respiratory fusion virus nucleic acid reagent

TW: 羅氏可霸斯A型/B型流感/呼吸道融合病毒核酸試劑

Taiwan·Risk Class 2·Roche Molecular Systems, Inc.·Registered May 25, 2018 – May 25, 2023Expired

Registration details

Analysis ID: d1dd1d6a00f7f328d6f6eb061d0a56f6
Customs Code: DHA05603112407

Company information

Manufacturer: Roche Molecular Systems, Inc.
Manufacturer Country: United States
Authorized Representative: ROCHE DIAGNOSTICS LTD.

Product details

Intended Use: This product is suitable for Cobas Liat System, which uses automated multiplex real-time reverse transcription polymerase chain reaction in nasopharyngeal swab samples of patients with signs and symptoms of respiratory infection to qualitatively detect and distinguish between influenza A, B and respiratory fusion virus (RNA of RSV, test results), and should be evaluated in combination with clinical and epidemiological risk factors.
Product Type (Level 1): C Immunology and Microbiology; A Clinical chemistry and clinical toxicology
Product Type (Level 2): C.3980 Nucleic acid test for respiratory viruses; A.1660 Quality control materials (analytical and non-analytical)
Import Information: import

Dates and status

Registration Date: May 25, 2018
Expiry Date: May 25, 2023

About this record

Access comprehensive regulatory information for Roche Cobas influenza A/B/respiratory fusion virus nucleic acid reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number d1dd1d6a00f7f328d6f6eb061d0a56f6 and manufactured by Roche Molecular Systems, Inc.. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..

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