Taiwan FDA registration 64a312a80525783067e8dab334c5ebe2

Roche Kebaslater new coronavirus and A/B flu test reagent

TW: 羅氏可霸斯萊特新冠病毒與 A/B 流感檢驗試劑

Taiwan·Risk Class 3·Roche Molecular Systems, Inc.;; ROCHE DIAGNOSTICS GMBH·Registered Nov 13, 2023 – Nov 13, 2028Active

Registration details

Analysis ID: 64a312a80525783067e8dab334c5ebe2
Customs Code: DHA05603623400

Company information

Manufacturer: Roche Molecular Systems, Inc.;; ROCHE DIAGNOSTICS GMBH
Manufacturer Country: United States;;Germany
Authorized Representative: ROCHE DIAGNOSTICS LTD.

Product details

Intended Use: This product is suitable for use in the cobas Liat system, which uses multiple reverse transcription polymerase to automatically react in real time to qualitatively detect and distinguish whether there is SARS-CoV-2, influenza A and B viral RNA in nasopharyngeal and nasal swabs from individuals with suspected viral respiratory infection. This product is intended for the detection and differentiation of SARS-CoV-2, influenza A and B nucleic acids in clinical specimens, and is not intended for the detection of influenza C virus. In the acute phase of infection, viral RNA from SARS-CoV-2, influenza A, and influenza B can be detected, usually in respiratory specimens. A positive result indicates an active infection, but cannot rule out a bacterial infection or co-infection with other pathogens that is not detectable by this test. Clinical relevance to the patient's medical history and other diagnostic information is necessary to determine the patient's infection status. The detected pathogen may not be the exact cause of the disease. A negative result does not rule out SARS-CoV-2, influenza A and/or B infection and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Negative results must be combined with clinical observation, patient history, and/or epidemiological information.
Product Type (Level 1): B Hematology, Pathology and Genetics;; 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 for respiratory viruses; B.4020 Analysis of specific tests
Import Information: QMS/QSD;; 輸入

Dates and status

Registration Date: Nov 13, 2023
Expiry Date: Nov 13, 2028

About this record

Access comprehensive regulatory information for Roche Kebaslater new coronavirus and A/B flu test reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 64a312a80525783067e8dab334c5ebe2 and manufactured by Roche Molecular Systems, Inc.;; ROCHE DIAGNOSTICS GMBH. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..

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