FDA 510(k) Applications for Medical Device Product Code: MYF (Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2)

FDA 510(k) Applications for Medical Device Product Code "MYF"
(Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K181334	Biokit, S.A.	ADVIA Centaur Herpes-2 IgG	08/23/2018
K081687	DIASORIN, INC.	LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG	11/10/2008
K061239	EUROIMMUN US LLC	EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KIT	06/28/2007
K993724	MRL DIAGNOSTICS	HSV-2 ELISA IGG, MODEL EL0920G	02/01/2000
K181514	Quest International, Inc.	SeraQuest HSV Type 2 Specific IgG	06/13/2019
K152353	Quest International, Inc.	SeraQuest HSV Type 2 Specific IgG	05/13/2016
K220924	Roche Diagnostics	Elecsys HSV-2 IgG (08948887160)	10/12/2022
K033106	TRINITY BIOTECH USA	CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT	07/13/2004
K103603	ZEUS SCIENTIFIC, INC.	ZEUS ELISA HSV GG-2 IGG TEST SYSTEM	05/20/2011