SeraQuest Herpes Type 1 Specific IgG— 510(k) K162276

Name: FDA 510(k) clearance K162276
Creator: U.S. Food and Drug Administration
Published: 2016-10-01

Substantially Equivalent

Quest International, Inc.

FDA 510(k) clearance K162276 for SeraQuest Herpes Type 1 Specific IgG, Substantially Equivalent on 2016-10-01. Applicant: Quest International, Inc.. Device class: 2.

Clearance details

Applicant: Quest International, Inc.
Product code: Code MXJ
Device class: Class 2
Regulation: 21 CFR 866.3305
Advisory panel: Microbiology
Date received: 2016-08-12
Decision date: 2016-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mami, FL, US

Download summary PDF View on FDA.gov ↗

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K220923 — Elecsys HSV-1 IgG (08948844160)2022-10-12
K181333 — ADVIA Centaur Herpes-1 IgG2018-08-23
K143236 — Theranos Herpes Simplex Virus-1 IgG Assay2015-07-02
K131334 — HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST2014-02-28

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K181514 — SeraQuest HSV Type 2 Specific IgG2019-06-13
K152353 — SeraQuest HSV Type 2 Specific IgG2016-05-13

Adverse events under product code MXJ

product code MXJ

Injury: 139
Total: 139

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.