Quidel Corp.’s Strep-Throat Test Gets FDA ApprovalSunday, January 5, 2014
Quidel Corp. has received regulatory clearance for its hand-held test that diagnoses strep throat.
The Food and Drug Administration granted 510(k) clearance for Quidel’s AmpliVue Group B Strep Assay, which tests for streptococcus bacteria that can lead to conditions ranging from simple throat infections to pneumonia and meningitis, the company said.
Shares for Quidel (Nasdaq: QDEL) rose 39 cents following the announcement, closing at $29.89 on Jan. 3. The company has a market capitalization of $1 billion.