Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2

FDA product code MYF · Class II (moderate risk) · 21 CFR 866.3305 · Microbiology

10510(k) clearances
0PMA approvals
2recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K243575ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG ControlsMYF · Traditional Biokit, S.A.02/12/2025SE
K220924Elecsys HSV-2 IgG (08948887160)MYF · Traditional Roche Diagnostics10/12/2022SE
K181514SeraQuest HSV Type 2 Specific IgGMYF · Traditional Quest International, Inc.06/13/2019SE
K181334ADVIA Centaur Herpes-2 IgGMYF · Traditional Biokit, S.A.08/23/2018SE
K152353SeraQuest HSV Type 2 Specific IgGMYF · Traditional Quest International, Inc.05/13/2016SE
K103603Zeus Elisa HSV GG-2 Igg Test SystemMYF · Traditional Zeus Scientific, Inc.05/20/2011SE
K081687Liaison HSV-2 Type Specific Igg Assay, Control HSV-2 IggMYF · Traditional DiaSorin, Inc.11/10/2008SE
K061239Euroimmun ANTI-HSV-2 Elisa (Igg) and ANTI-HSV-1 Elisa (Igg) KitMYF · Traditional Euroimmun Us, LLC06/28/2007SE
K033106Captia HSV 2 Igg Type Specific Elisa KitMYF · Traditional Trinity Biotech USA07/13/2004SE
K993724HSV-2 Elisa Igg, Model EL0920GMYF · Traditional Mrl Diagnostics02/01/2000SE

Recalls

RecallProductFirmInitiated
Z-0815-2024 Class IIDiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620DiaSorin has identified that lots 136344, 136344A, 136344B, 136344C, 136520, 136520A, 136520B, 136520C… Diasorin Inc.12/13/2023Open, Classified
Z-1274-2021 Class IIEnzyme linked immunosorbent assay, for herpes simplex virus, hsv-2Potential false positive HSV results. Siemens Healthcare Diagnostics, Inc. initiated a correction for ADVIA… Siemens Healthcare Diagnostics, Inc02/08/2021Terminated