ClearanceBrief
510(k) DEN140004 ยท PGI Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples

QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY

ApplicantDiagnostic Hybrids, Inc., Athens OH, US
DecisionUnknown, May 13, 2014
ReceivedFeb 21, 2014
TypePost-NSE
FDA recordOpen on fda.gov

Recalls that name DEN140004

No recall in the FDA data names this 510(k).

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.