Molecular Diagnostic / RT-PCR Molecular Control Kit Cobas® Liat® SARS-CoV-2 and Influenza A / B Positive Level / Negative Level 3 X 0.25 mL / 3 X 10 µL / 3 X 0.3 mL
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Molecular Diagnostic / RT-PCR Molecular Control Kit Cobas® Liat® SARS-CoV-2 and Influenza A / B Positive Level / Negative Level 3 X 0.25 mL / 3 X 10 µL / 3 X 0.
For use with cobas® SARS-CoV-2 and Influenza Nucleic Acid Test on the cobas® Liat® System
Form
Liquid
Levels
Positive Level / Negative Level
Product Dating
SLI Medical Acceptable Dating: we will ship >= 30 days
Storage Requirements
Requires Refrigeration
Test Name
SARS-CoV-2 and Influenza A / B
Test Type
Molecular Diagnostic / RT-PCR
UNSPSC Code
41116145
Volume
3 X 0.25 mL / 3 X 10 µL / 3 X 0.3 mL
Features
The cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test is for use on the cobas Liat System under FDA Emergency Use Authorization: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
Emergency use of this test is limited to authorized laboratories: Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA)
42 U.S.C. §263a
to perform moderate or high complexity tests
The cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat System is also authorized for use at the Point of Care (POC)
i.e.
in patient care settings operating under a CLIA Certificate of Waiver
Certificate of Compliance
or Certificate of Accreditation
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
This test has been authorized only for the simultaneous qualitative detection and differentiation of nucleic acid from SARS-CoV-2
influenza A virus
and influenza B virus and not for any other viruses or pathogens
This test is only authorized in the United States for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food
Drug
and Cosmetic Act
21 U.S.C. § 360bbb-3(b)(1)
unless the authorization is terminated or revoked sooner
Positive results are indicative of active infection but do not rule out bacterial infection or co-infection with other pathogens not detected by the test; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status
Negative results do not preclude SARS-CoV-2
influenza A
and/or influenza 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 observations
patient history
and/or epidemiological information
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
Includes: 11 Transfer Pipettes and 1 Control Kit Barcode Card
3 X 0.25 mL SARS-Cov-2 (+)
Molecular Diagnostic / RT-PCR Molecular Control Kit Cobas® Liat® SARS-CoV-2 and Influenza A / B Positive Level / Negative Level 3 X 0.25 mL / 3 X 10 µL / 3 X 0.
