Nucleic acid-based in vitro diagnostic devices for the detection of 2019-n ...



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.
Components:
Recall Date:    Jan 5, 2021
Mfg:
Biomeme, Inc.
Mfg Country:
United States
Recall ID:    87153
Product ID:    185447
Enforcement Date:    Feb 10, 2021
Termination Date:    Jun 11, 2021
Last Published:    Jun 11, 2021

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Emert Number:    Z-0940-2021
Emert Status:    Terminated