Biomeme Franklin User Manual

Franklin™ Real-Time PCR
Thermocycler w/
Biomeme Go App (EUA)
For IVD Use ONLY. For Emergency Use Authorization ONLY.
This product has not been FDA cleared or approved; the product has been authorized by FDA for use with
the Biomeme SARS-CoV-2 Real-Time RT-PCR Test 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.
This product has been authorized only for use with the Biomeme SARS-CoV-2 Real-Time RT-PCR Test for
the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.
This product is only authorized for the duration of the declaration that circumstances exist justifying the
authorization of emergency use of in vitro diagnostics 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.
Last Updated: ​ 0 8/12/2020