Roche Slater Slater influenza A/B/respiratory fusion virus nucleic acid reagent - Taiwan Registration 1323b1781a496e49c611130e0dd7104d
Access comprehensive regulatory information for Roche Slater Slater 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 1323b1781a496e49c611130e0dd7104d and manufactured by ROCHE MOLECULAR SYSTEMS, INC.. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..
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Device Details
Product Details
This product is suitable for cobas Liat system, which uses automated multiplex real-time reverse transcription polymerase chain reaction to detect nasopharyngeal swab specimens with signs and symptoms of respiratory infection and patients with clinical and epidemiological risk factors, and quickly and qualitatively detect and distinguish RNA of influenza A, B and respiratory fusion virus (RSV). This product is intended to aid in the identification and diagnosis of influenza A, influenza B, and respiratory fusion virus (RSV), and is not intended to detect influenza C.
A Clinical Chemistry and Clinical Toxicology;; C Immunology and Microbiology
A.1660 Quality control materials (analytical and non-analytical); C.3980 Nucleic acid test agent for respiratory viruses
QMS/QSD;; ่ผธๅ ฅ
Dates and Status
Jun 30, 2022
Jun 30, 2027