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    Biomeme RNA Process Control (RPC) Kiit

    FDA UDI
    Biomeme, Inc.·00810096640079·RNA Process Control for Biomeme's SARS-CoV-2 as...

    Biomeme SARS-CoV-2 Go-Plates Kit

    FDA UDI
    Biomeme, Inc.·00810096640086·Pre-aliquoted 96-well PCR plate. Each well cont...

    Biomeme Franklin three9 Real-Time PCR Thermocycler

    FDA UDI
    Biomeme, Inc.·00810096640024·Portable, battery-operated real-time PCR and is...

    Biomeme M1 Sample Prep Cartridge Kit for RNA 2.0

    FDA UDI
    Biomeme, Inc.·00810096640031·RNA Extraction Kit containing cartridges, syrin...

    Biomeme Franklin three9 Real-Time PCR Thermocycler

    FDA UDI
    Biomeme, Inc.·00810096640116·Portable, battery-operated real-time PCR and is...

    Biomeme Void Filling Caps

    FDA UDI
    Biomeme, Inc.·00810096640062·Void Filling Caps for sealing Biomeme PCR Go-St...

    Biomeme SARS-CoV-2 Go-Plates

    FDA UDI
    Biomeme, Inc.·00810096640093·Pre-aliquoted 96-well PCR plate. Each well cont...

    Biomeme GoDx App for US

    FDA UDI
    Biomeme, Inc.·00810096640130·App for controlling Biomeme Frankin three9 ther...

    Biomeme SARS-CoV-2 Go-Strips Kit

    FDA UDI
    Biomeme, Inc.·00810096640048·Pre-aliquoted 3-well PCR strips. Each well cont...

    Biomeme Franklin three9 Real-Time PCR Thermocycler

    FDA UDI
    Biomeme, Inc.·00810096640017·Portable, battery-operated real-time PCR and is...

    Biomeme DNA/RNA Preservation Buffer (100/pk)

    FDA UDI
    Biomeme, Inc.·00810096640109·Tubes filled with 3mL aliquots of Biomemes DNA/...

    Biomeme Franklin three9 Real-Time PCR Thermocycler

    FDA UDI
    Biomeme, Inc.·00810096640123·Portable, battery-operated real-time PCR and is...

    Biomeme SARS-CoV-2 Go-Strips

    FDA UDI
    Biomeme, Inc.·00810096640055·Pre-aliquoted 3-well PCR strips. Each well cont...

    BIOMEME SARS-COV-2 REAL-TIME RT-PCR TEST

    FDA Adverse Event
    Malfunction ·BIOMEME, INC.·Product code QJR·October 13, 2021

    Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCoV) and/or diagnosis of 2019-nCoV infection in human clinical specimens. The RT-PCR test runs on a Franklin Real-Time PCR Thermocycler Device (Reference/Catalog Number 1000003,1000018) with the Software Controller version 6.4.3. The cycler has a "baseboard" unit with firmware and associated software component that control motorized movements of the optical filter carriage used for PCR detection.

    FDA Recall
    Terminated ·Biomeme, Inc.·Product code QJR·January 5, 2021

    Biomeme SARS-CoV-2- Real Time RT-PCR Test, Instructions for Use, Part number 100002824 Subcomponent of: SARS-CoV-2 Go-Strips, 3000555; SARS-CoV-2 Go-Plates, 3000562; SARS-Cov-2 Bulk Vials, 3000564

    FDA Recall
    Terminated ·Biomeme, Inc.·Product code QJR·October 20, 2021

    The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is a molecular in vitro diagnostic test that is based on widely used nucleic acid amplification technology. The Biomeme SARS-CoV-2 Real-Time RT-PCR Test contains primers and probes and internal controls used in RT-PCR for the in vitro qualitative detection of SARS-CoV-2 RNA in upper respiratory specimens. The Biomeme SARS-CoV-2 Real-Time RT-PCR Test utilizes Biomemes M1 Sample Prep Cartridge for RNA extraction, Biomemes SARS-CoV-2 Go-Strips assay, and Biomemes portable Franklin" Real-Time qPCR Thermocycler. Franklins companion mobile app, Biomeme Go, scans tests, runs PCR experiments online or offline, and is used to quickly interpret your test results while conveniently syncing data to the Biomeme Cloud. Biomeme: 1000013 (Android Smartphone w/ Biomeme Go Mobile App) and Biomeme: 1000012 (Rugged Android Smartphone w/ Biomeme Go Mobile App) are controller for Biomeme Franklin thermocycler.

    FDA Recall
    Terminated ·Biomeme, Inc.·Product code QJR·October 23, 2020

    Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCoV) and/or diagnosis of 2019-nCoV infection in human clinical specimens. The RT-PCR test runs on a Franklin Real-Time PCR Thermocycler Device (Reference/Catalog Number 1000003,1000018) with the Software Controller version 6.4.3. The cycler has a "baseboard" unit with firmware and associated software component that control motorized movements of the optical filter carriage used for PCR detection.

    FDA Enforcement
    Class III ·Terminated·Biomeme, Inc.·February 10, 2021

    The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is a molecular in vitro diagnostic test that is based on widely used nucleic acid amplification technology. The Biomeme SARS-CoV-2 Real-Time RT-PCR Test contains primers and probes and internal controls used in RT-PCR for the in vitro qualitative detection of SARS-CoV-2 RNA in upper respiratory specimens. The Biomeme SARS-CoV-2 Real-Time RT-PCR Test utilizes Biomemes M1 Sample Prep Cartridge for RNA extraction, Biomemes SARS-CoV-2 Go-Strips assay, and Biomemes portable Franklin" Real-Time qPCR Thermocycler. Franklins companion mobile app, Biomeme Go, scans tests, runs PCR experiments online or offline, and is used to quickly interpret your test results while conveniently syncing data to the Biomeme Cloud. Biomeme: 1000013 (Android Smartphone w/ Biomeme Go Mobile App) and Biomeme: 1000012 (Rugged Android Smartphone w/ Biomeme Go Mobile App) are controller for Biomeme Franklin thermocycler.

    FDA Enforcement
    Class II ·Terminated·Biomeme, Inc.·December 9, 2020

    Biomeme SARS-CoV-2- Real Time RT-PCR Test, Instructions for Use, Part number 100002824 Subcomponent of: SARS-CoV-2 Go-Strips, 3000555; SARS-CoV-2 Go-Plates, 3000562; SARS-Cov-2 Bulk Vials, 3000564

    FDA Enforcement
    Class II ·Terminated·Biomeme, Inc.·January 12, 2022