Panels › Microbiology › Product code MYF · Class 2

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

Regulation 866.3305

0510(k)s in 12 months (10 all time)

0recalls in 12 months (2 all time)

2recalls that name a 510(k)

Top companies in MYF

Company	510(k)s	Recalls
Biokit, S.A.	2	0
DiaSorin, Inc.	1	1
Quest International, Inc.	2	0
Euroimmun Us, LLC	1	0
Mrl Diagnostics	1	0
Roche Diagnostics	1	0
Siemens Healthcare Diagnostics, Inc	0	1
Trinity Biotech USA	1	0
Zeus Scientific, Inc.	1	0

Date	Firm and product	Code	Linked 510(k)
Jan 25, 2024	Diasorin Inc. DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620 Open, Classified	MYF	K081687
Mar 18, 2021	Siemens Healthcare Diagnostics, Inc Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2 Terminated	MYF	K181334

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