MYF · Class II · 21 CFR 866.3305

FDA Product Code MYF: Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2

Leading manufacturers include Quest International, Inc., Biokit, S.A. and Trinity Biotech USA.

10
Total
10
Cleared
212d
Avg days
2000
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times improving: avg 85d recently vs 226d historically

FDA 510(k) Cleared Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 Devices (Product Code MYF)

10 devices
1–10 of 10
Cleared Feb 12, 2025
ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls
K243575
Biokit, S.A.
Microbiology · 85d
Cleared Oct 12, 2022
Elecsys HSV-2 IgG (08948887160)
K220924
Roche Diagnostics
Microbiology · 195d
Cleared Jun 13, 2019
SeraQuest HSV Type 2 Specific IgG
K181514
Quest International, Inc.
Microbiology · 370d
Cleared Aug 23, 2018
ADVIA Centaur Herpes-2 IgG
K181334
Biokit, S.A.
Microbiology · 94d
Cleared May 13, 2016
SeraQuest HSV Type 2 Specific IgG
K152353
Quest International, Inc.
Microbiology · 267d
Cleared May 20, 2011
ZEUS ELISA HSV GG-2 IGG TEST SYSTEM
K103603
Zeus Scientific, Inc.
Microbiology · 163d
Cleared Nov 10, 2008
LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG
K081687
DiaSorin, Inc.
Microbiology · 146d
Cleared Jun 28, 2007
EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KIT
K061239
Euroimmun Us, LLC
Microbiology · 421d
Cleared Jul 13, 2004
CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT
K033106
Trinity Biotech USA
Microbiology · 287d
Cleared Feb 01, 2000
HSV-2 ELISA IGG, MODEL EL0920G
K993724
Mrl Diagnostics
Microbiology · 90d

About Product Code MYF - Regulatory Context

510(k) Submission Activity

10 total 510(k) submissions under product code MYF since 2000, with 10 receiving FDA clearance (average review time: 212 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - MYF Product Code

Recent submissions under MYF have taken an average of 85 days to reach a decision - down from 226 days historically, suggesting improved FDA processing for this classification.

MYF devices are reviewed by the Microbiology panel. Browse all Microbiology devices →