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Roche Cobas influenza A/B/respiratory fusion virus nucleic acid reagent - Taiwan Registration d1dd1d6a00f7f328d6f6eb061d0a56f6

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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d1dd1d6a00f7f328d6f6eb061d0a56f6
Registration Details
Taiwan FDA Registration: d1dd1d6a00f7f328d6f6eb061d0a56f6
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Device Details

Roche Cobas influenza A/B/respiratory fusion virus nucleic acid reagent
TW: ็พ…ๆฐๅฏ้œธๆ–ฏAๅž‹/Bๅž‹ๆตๆ„Ÿ/ๅ‘ผๅธ้“่žๅˆ็—…ๆฏ’ๆ ธ้…ธ่ฉฆๅŠ‘
Risk Class 2

Registration Details

d1dd1d6a00f7f328d6f6eb061d0a56f6

DHA05603112407

Company Information

United States

Product Details

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.

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