FDA submission
The company has completed its FDA submission for the system and inked a deal with UAE-based healthcare provider Burjeel Holdings to deploy the system in its facilities.
Co-Diagnostics Withdraws FDA COVID Test Submission, Plans New Version of Test
The company now intends to submit an enhanced version of its COVID-19 test for 510(k) clearance.
Fujirebio Files Blood-Based Alzheimer's Test With FDA
The test measures levels of p-tau 217 and β-Amyloid 1-42 in human plasma to identify patients with the amyloid brain pathology characteristic of Alzheimer's disease.
Nuclein Submits Combo COVID, Flu Point-of-Care RT-qPCR Test for FDA 510(k) Clearance, CLIA Waiver
The cartridge-based test detects SARS-CoV-2, influenza A, and influenza B in approximately 15 minutes.
QuidelOrtho Withdraws Submitted Savanna Respiratory Panel, Obtains FDA Clearance for COVID-19 Test
The firm said the final performance data for the Savanna RVP4+ panel did not meet its expectations, and it will now resubmit a next-gen version.
Dec 15, 2021
Enzo Biochem Q1 2022 Revenues Down 8 Percent
Nov 16, 2021