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ELISA For Herpes Simplex Virus

by Scientific Research

510(k) K843077

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK843077 Date21 Jun 1985ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

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

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The ELISA For Herpes Simplex Virus is an enzyme-linked immunosorbent assay used for the detection of antibodies to the herpes simplex virus. This diagnostic test helps identify whether a person has been infected with HSV by detecting specific antibodies in the blood sample. The assay is designed to provide serological results for both HSV-1 and HSV-2 types.

This device is supplied as a non-specific test for laboratory use and is classified as a Class II medical device. It is not specified as single-use or reusable, and no MRI safety information is provided. The device is authorized under FDA 510K clearance with product code LGC and is manufactured by Scientific Research. It is intended for use in microbiology laboratories for diagnostic purposes.

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