FDA Authorizes Imported Becton Dickinson Sodium Citrate Blood Specimen Collection (Light Blue Top) Tubes,SARS-CoV-2 Variant Classification Updates,FDA Revokes EUA for Curative SARS-CoV-2 assay

COLA Inc. is engaged with the CDC’s Laboratory Outreach Communication System (LOCS) in the Division of Laboratory Systems (DLS) to transmit their public health messages to our laboratories and affiliates. Below are the most recent updates within LOCS:

Below are the links to the most recent updates within LOCS:

On July 26th, the CDC announced that the FDA has issued an emergency use authorization (EUA) to Becton Dickinson and Company (BD) for its BD Vacutainer Plus Citrate Plasma Tubes (UK Manufacturing Site), which are sodium citrate blood specimen collection tubes used to collect, transport, and store blood samples for coagulation testing. The device authorized under this EUA is for use in coagulation testing by CLIA-certified laboratories performing non-waived testing, to aid in the identification and treatment of coagulopathy in patients, including (but not limited to) patients with known or suspected COVID-19.

On July 20th, the CDC updated the SARS-CoV-2 Variant Classifications. The SARS-CoV-2 variant AY.3 is being aggregated with Delta variant B.1.617.2.

On July 8th, the CDC announced that the FDA has revoked emergency use authorization for Curative SARS-CoV-2 assay.