fda
3 records
FDA Device Recall: Biomeme SARS-CoV-2- Real Time RT-PCR Test, Instructions for Use, Part number 100
2022-01-12
Class II — The current IFU specifies a shelf-life of one week after resuspension of the RPC Buffer when stored at room temperature. Ongoing stability studies have indicated the need to shorten the lif...
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FDA Device Recall: Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel c
2021-02-10
Class III — Users cannot complete testing due to a sign-error in the software component that controls the filter movement and results in an instrument failure and assay failure before results are gene...
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FDA Device Recall: The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is a molecular in vitro diagnostic
2020-12-09
Class II — The firm has become aware of nine reports by a single customer that the software made false positive calls. The investigation determined that the root cause is the higher than expected ambe...
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lobbying
1 records
Lobbying Client: BIOMEME, INC.
Lobbied by MILNE, WIENER & SHOFE GLOBAL STRATEGIES (FKA M & W GOVERNMEN — Company has developed a rapid pcr test for covid-19 and an array of chem-bio threats
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ny_corps
1 records
NY Corp: BIOMEME, INC.
2022-08-26
FOREIGN BUSINESS CORPORATION | County: New York | Jurisdiction: Delaware
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