SeraQuest HSV Type 2 Specific IgG

FDA 510(k) K152353 · Quest International, Inc.

Substantially Equivalent

510(k) numberK152353

Submission

Device name
SeraQuest HSV Type 2 Specific IgG
Applicant
Quest International, Inc.
Mami, FL, US
Received
August 20, 2015
Decision date
May 13, 2016
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MYF – Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3305
Specialty
Microbiology

Other 510(k)s with product code MYF

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
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

More from Mrl Diagnostics

510(k)DeviceDecision
K181514SeraQuest HSV Type 2 Specific IgGMYF · Traditional 06/13/2019SE
K162276SeraQuest Herpes Type 1 Specific IgGMXJ · Traditional 10/01/2016SE

Questions and answers

When was SeraQuest HSV Type 2 Specific IgG cleared by the FDA?

SeraQuest HSV Type 2 Specific IgG (K152353) received a 510(k) decision of Substantially Equivalent on May 13, 2016, 267 days after the submission was received.

What is the product code of K152353?

The FDA product code is MYF – Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2, a Class II (moderate risk) device regulated under 21 CFR 866.3305.