360Dx

Diasorin Gains FDA 510(k) Clearance for Multiplex Respiratory Test

The Simplexa COVID-19/Flu A/B  & RSV Direct Kit is used for the detection and differentiation of infections with SARS-CoV-2, flu A/B, and respiratory syncytial viruses.
News Medical

FDA grants 510(k) clearance for QIAGEN’s molecular detection PCR technology

QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced that the U.S. Food and Drug Administration (FDA) has granted two 510(k) clearances for its real-time PCR (polymerase chain ...
Medindia

QIAGEN Receives FDA Clearances for Rotor-Gene Q MDx Instrument and Compatible Influenza A/B Assay

QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced that the U.S. Food and Drug Administration (FDA) has granted two 510(k) clearances for its real-time PCR (polymerase chain ...
Business Wire

Applied BioCode’s Syndromic Gastrointestinal Pathogen Panel Approved by the FDA on BioCode® MDx-3000 System

SANTA FE SPRINGS, Calif.--(BUSINESS WIRE)--Applied BioCode announced that it has received U.S. Food and Drug Administration 510(k) clearance for BioCode Gastrointestinal Pathogen Panel (GPP) with high ...
Business Wire

Applied BioCode Submits 510(k) Application to FDA for BioCode MDx-3000 with Gastrointestinal Pathogen Panel

SANTA FE SPRINGS, Calif.--(BUSINESS WIRE)--Applied BioCode announced today that it has submitted the BioCode MDx-3000 with 18-Plex Gastrointestinal Pathogen Panel (GPP) to the U.S. Food and Drug ...