Seeking Alpha

Quidel receives FDA 510K clearance for its RSV immunoassay test

  • Quidel (QDEL +0.1%) ticks up after saying it's received FDA 510(k) clearnace for its Sofia RSV Fluorescent Immunoassay test for use with its Sofia Analyzer, for the detection of respiratory syncytial virus infections.
  • The clearance allows it to market and sell its new Sofia RSV FIA in the United States.
  • The Sofia Analyzer was cleared in October of 2011, and in addition to the RSV application,
  • Sofia now enables rapid immunofluorescence assays for three other FDA-cleared FIAs: Influenza A+B, Strep A and hCG for pregnancy.
Comments (0)
Be the first to comment
DJIA (DIA) S&P 500 (SPY)
ETF Tools
Find the right ETFs for your portfolio:
Seeking Alpha's new ETF Hub
ETF Investment Guide:
Table of Contents | One Page Summary
Read about different ETF Asset Classes:
ETF Selector