Taiwan FDA registration c5454be6264ea819ed0b80a80c4f9061

Roche Cobas influenza A and B virus nucleic acid test reagent

TW: 羅氏可霸斯A型和B型流感病毒核酸檢驗試劑

Taiwan·Risk Class 2·ROCHE MOLECULAR SYSTEMS, INC.·Registered May 25, 2018 – May 25, 2023Expired

Registration details

Analysis ID: c5454be6264ea819ed0b80a80c4f9061
Customs Code: DHA05603112002

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 the Cobas Liat system, which uses multiplex reverse transcription polymerase to automatically react in real time to quickly detect and identify signs and symptoms of respiratory infection and whether influenza A and B virus RNA is present on the nasopharyngeal swab specimen of patients 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 and B virus nucleic acid test reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number c5454be6264ea819ed0b80a80c4f9061 and manufactured by ROCHE MOLECULAR SYSTEMS, INC.. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..

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