Fixed Volume Pipette (20µL)

This Fixed Volume Pipette enables you to easily transfer 20µL of your purified nucleic acids from your Biomeme Elution Buffer (BEB) into your Biomeme lyophilized test strip. These pipettes have been tested and approved for use with Biomeme M1 Sample Prep® Kits. Each pipette is designed to be exact +/- 10% and easy to use.

Each order includes the following:

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.