FDA Submission
Cue Health requests FDA de novo clearance for at-home flu test
September 1, 2022
FDA issues updated reagent, instrument guidance
August 15, 2022
Natera files presubmission with FDA for NIPT test
August 10, 2022
Abionic nabs IVDR certification for sepsis test
August 8, 2022
I-calQ receives 9th patent for smartphone POC testing
January 14, 2021
MDIC releases IVD regulatory decision-making framework
August 23, 2020
HHS: FDA review not needed for coronavirus LDTs
August 19, 2020
Abbott unveils lab-based COVID-19 antibody blood test
April 15, 2020
Myriad files companion BRCA test in prostate cancer
January 20, 2020
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