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Hsv 1+2 Igg Elisa Test

by Gull Laboratories, Inc. 510(k)

Active United States

510(k) K983541

Overview

The HSV 1+2 IGG ELISA TEST is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgG antibody to herpes simplex virus type 1 and type 2 in human serum. It is intended for use manually or in conjunction with the DUETTM Instrument.

The device is supplied as a test kit for laboratory use and is classified as a Class II medical device under FDA regulation number 866.3305. It received traditional 510(k) clearance (K983541) on February 26, 1999, and is substantially equivalent to a legally marketed predicate device.

AI-generated from registry data, 24 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK983541 Date26 Feb 1999ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
LGC
Device Class
Class II
Regulation
21 CFR Part 866.3305
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the HSV 1+2 IGG ELISA TEST used for?

    The HSV 1+2 IGG ELISA TEST is used for the qualitative detection of IgG antibody to herpes simplex virus type 1 and type 2 in human serum, aiding in the assessment of past or current infection when used as part of a broader diagnostic evaluation.

  • How is the HSV 1+2 IGG ELISA TEST supplied and what equipment is needed?

    The device is supplied as a test kit for laboratory use and can be performed manually or in conjunction with the DUETTM Instrument, which automates certain steps of the ELISA process to improve consistency and throughput in testing environments.

  • Is the HSV 1+2 IGG ELISA TEST reusable or single-use?

    The HSV 1+2 IGG ELISA TEST is designed for single-use per test well; reagents and components are intended for one-time application to prevent cross-contamination and ensure reliable qualitative results, consistent with standard ELISA kit protocols.