Diagnostic Hybrids
The vote of confidence is a stepping stone for the company to seek 510(k) approval for an H1N1 test on its platform; to tackle the point-of-care diagnostic market; and to further develop tests for other infectious diseases.
Longhorn Gets FDA Emergency Use Authorization for H1N1 Assay
The San Antonio-based firm also intends to file a 510(k) for clearance of the assay.
FDA Clears Diagnostic Hybrids Viral ID Test
The clearance covers a respiratory viral test for both RSV and hMPV.
Quidel Acquires Diagnostic Hybrids for $130M
Quidel said that Diagnostic Hybrids' fluorescent in vitro diagnostic assays would complement Quidel's point-of-care diagnostics for infectious disease and reproductive health.