Taiwan FDA registration 1323b1781a496e49c611130e0dd7104d

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

TW: 羅氏可霸斯萊特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 Jun 30, 2022 – Jun 30, 2027Active

Registration details

Analysis ID: 1323b1781a496e49c611130e0dd7104d
Customs Code: DHA05603566700

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 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.
Product Type (Level 1): A Clinical Chemistry and Clinical Toxicology;; C Immunology and Microbiology
Product Type (Level 2): A.1660 Quality control materials (analytical and non-analytical); C.3980 Nucleic acid test agent for respiratory viruses
Import Information: QMS/QSD;; 輸入

Dates and status

Registration Date: Jun 30, 2022
Expiry Date: Jun 30, 2027

About this record

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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