Molecular Reagent Cobas® Liat® SARS-CoV-2, Influenza A / B CLIA Waived For Cobas Liat System 20 Tests

Features

• cobas® SARS-CoV-2 & Influenza A/B nucleic acid test for use on the cobas® liat analyzer has successfully completed its transition from Emergency Use Authorization (EUA) product to 510(k) cleared product
• Product ships from McKesson with minimum 30 days dating
• The cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System (cobas® SARS-CoV-2 & Influenza A/B) is an automated rapid multiplex real-time, reverse transcriptase polymerase chain reaction (RT-PCR) test intended for the simultaneous qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A, and influenza B virus nucleic acid in nasopharyngeal swab (NPS) and anterior nasal swab (ANS) specimens from individuals with signs and symptoms of respiratory tract infection
• cobas® SARS-CoV-2 & Influenza A/B is intended for use as an aid in the differential diagnosis of SARS-CoV-2, influenza A, and/or influenza B infection if used in conjunction with other clinical and epidemiological information, and laboratory findings
• The new cobas SARS-CoV-2 & Influenza A/B test analyzes nucleic acids from nasopharyngeal and nasal swab samples and self-collected nasal swabs (collected in a healthcare setting with instruction by a healthcare provider) to enable frontline healthcare workers to quickly identify and differentiate these similarly presenting infections
• cobas® SARS-CoV-2 & Influenza A/B is intended for use by health professionals or trained operators who are proficient in using the cobas® Liat System
• The cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System (cobas® SARS-CoV-2 & Influenza A/B) is an automated multiplex real-time RT-PCR assay intended for the simultaneous rapid in vitro qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B virus RNA
• Kit includes: 20 tests, 2 cobas® transfer pipette packs (12 pipettes/pack - P/N 9329676001), 1 package insert barcode card, cobas Liat Internal Process Control, Proteinase K, cobas Liat Magnetic Glass Particles, Lysis buffer, wash buffer, Elution buffer, A/B Master Mix 1, A/B Master Mix 2, A/B Master Mix 3

More Information

• cobas Liat SARS-CoV-2 + Flu A+B 510k Clearance Customer Bulletin
• cobas SARS-CoV-2 + Flu A+B CLIA Waived IFU