Android Smartphone (Biomeme Go App Pre-Installed)

All Biomeme thermocyclers are conveniently controlled using a smartphone running our user-friendly Biomeme Go mobile app. Biomeme Go is architected to work on both iOS and Android smartphones. The app comes pre-installed, essentially turning your smartphone into a mobile PCR lab enabling you to program thermocycling protocols, run, monitor, and analyze your PCR tests online or offline, quickly interpret your real-time test results, and securely sync data to the Biomeme Cloud to track and manage everything in one place.

Highlights

• Simple PCR Data Management: manage and analyze PCR data as it’s stored and get instant, tangible results that you can respond to, all from a single interface.

• Streamlined Protocol Management: select a standard protocol or create and save your own custom protocols by adjusting denature temps, times, and more.

• Integrated Barcode Scanner: minimize human errors by opting to scan your tests and sample IDs to improve accuracy, productivity, and efficiency.

• Real-Time Results: display results from qualitative or quantitative tests in real-time or choose to share to Excel, Google Sheets, etc.

Components

Resources

• Manual: Biomeme Go Mobile App

• Video: Biomeme Go Overview

Certificates

• Biomeme SARS-CoV-2 Real-Time RT-PCR Test - Letter of Authorization from FDA

• Biomeme Software Security Statement

IVD (EUA) Regulatory Statement

For Use Under an Emergency Use Authorization (EUA) Only. Rx Only | For In-Vitro Diagnostic Use.

This IVD product is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a that meet requirements to perform high complexity tests.

DISCLAIMERS:

• This test has not been FDA cleared or approved;
• This test has been authorized by FDA under an EUA for use by authorized laboratories;
• This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and
• This test 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 Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

RUO Regulatory Statement

For Research Use Only (RUO). Not for use in human or veterinary diagnostics.