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Histoplasma Capsulatum, Antiserum

by Meridian Diagnostics, Inc. 3 variants

510(k) K792718

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 NumberK792718 Date17 Jan 1980ClearedStatusActive

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  • Withdrawn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
GMK
Device Class
Class II
Regulation
21 CFR Part 866.3320
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

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

HISTOPLASMA CAPSULATUM, ANTISERUM is an antiserum used as a positive control in serological assays for the detection of Histoplasma capsulatum, a fungus that causes histoplasmosis. It is intended to validate the accuracy of diagnostic tests by providing a known reference material.

The device is supplied as a reference material and is not intended for single use. It is classified as FDA Class 2 (moderate risk) and has been cleared under FDA 510(k) with the K792718 number. Proper storage and handling are required to maintain its efficacy.

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Questions

AI-generated answers, 21 Sep 2026

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

  • What is this antiserum used for?

    It is a reference material used as a positive control in serological assays to validate the accuracy of diagnostic tests for Histoplasma capsulatum.

  • Is this product intended for single use?

    No, the device is supplied as a reference material and is not intended for single use.

  • How should this antiserum be stored?

    Proper storage and handling are required to maintain its efficacy, though the specific storage conditions are not detailed in the provided data.

  • What is the regulatory status of this device?

    It is classified as FDA Class 2 and has been cleared under FDA 510(k) with the K792718 number.