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Roche Cobas influenza A and B virus nucleic acid test reagent - Taiwan Registration c5454be6264ea819ed0b80a80c4f9061

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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c5454be6264ea819ed0b80a80c4f9061
Registration Details
Taiwan FDA Registration: c5454be6264ea819ed0b80a80c4f9061
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Device Details

Roche Cobas influenza A and B virus nucleic acid test reagent
TW: ็พ…ๆฐๅฏ้œธๆ–ฏAๅž‹ๅ’ŒBๅž‹ๆตๆ„Ÿ็—…ๆฏ’ๆ ธ้…ธๆชข้ฉ—่ฉฆๅŠ‘
Risk Class 2

Registration Details

c5454be6264ea819ed0b80a80c4f9061

DHA05603112002

Company Information

United States

Product Details

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.

C Immunology and Microbiology; A Clinical chemistry and clinical toxicology

C.3980 Nucleic acid test for respiratory viruses; A.1660 Quality control materials (analytical and non-analytical)

import

Dates and Status

May 25, 2018

May 25, 2023