MXJClass II

Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1

21 CFR 866.3305 / Microbiology

MXJ is the FDA product code for Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1, a class II device type, regulated under 21 CFR 866.3305. As of 2026-09-10, FDA records hold 20 510(k) clearances under this code, the most recent dated 2023-09-20, and no recalls.

Classification record

Product code: MXJ
Device name: Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
Regulation: 21 CFR 866.3305
Device class: Class II
Review panel: Microbiology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 20
Ingested recalls: 0

Clearances, product code MXJ

By decision year

20 clearances under product code MXJ with a decision year between 1999 and 2023, 2007 the highest year at 3.

Show the numbers

510(k) clearances under FDA product code MXJ by decision year
Year	Clearances
1999	1
2000	1
2002	2
2004	1
2007	3
2008	2
2009	1
2011	1
2012	2
2014	1
2015	1
2016	1
2018	1
2022	1
2023	1

Applicants with the most clearances

Product code MXJ

Applicants holding the most 510(k) clearances under product code MXJ
Applicant	Clearances
DiaSorin Molecular LLC	3
Bio-Rad Laboratories Inc.	2
Biokit, S.A.	2
Focus Technologies, Inc.	2
Roche Diagnostics GmbH	2
Zeus Scientific LLC	2
Diasorin Inc.	1
Gold Standard Diagnostics, LLC	1
Meridian Diagnostics, Inc.	1
Mrl Diagnostics	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order