Qualitative Assay for use on the MDx-3000 system
Authorized for Emergency Use by FDA under Emergency Use Authorization (EUA)*
For in vitro diagnostics use
The BioCode® SARS-CoV-2 Assay* is designed to detect two different conserved regions of SARS-CoV-2 N gene. The Assay does not detect common coronaviruses (OC43, HKU1, NL63, and 229E, MERS-CoV, or SARS-CoV).
The test is intended for the qualitative detection of SARS-CoV-2 in upper respiratory specimens such as nasopharyngeal swabs (NPS), oropharyngeal swabs (OPS), and nasal swabs or bronchoalveolar lavage (BAL) from individuals who are suspected of COVID-19 by their healthcare provider.
Delivers up to 564 sample results in a day (188 patient samples in an 8-hour shift)
Pooled testing of up to 5 individual upper respiratory specimens (NPS, OPS, and nasal swabs)
Parallel testing with FDA-cleared BioCode® assays
Please call 1-562-777-9800
or email orders@apbiocode.com
Part No.64-C0304
*The BioCode® SARS-CoV-2 Assay has not been FDA cleared or approved; the test has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) for use by laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, 42 U.S.C. §263a, that meet requirements to perform high complexity tests. The BioCode® SARS-CoV-2 Assay has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.
Emergency use of the BioCode® SARS-CoV-2 Assay is only authorized 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.
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