Gibco Herpes ID Kit

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K841943 ↗

FDA Product Code

GQL

Device Class

Class II

Regulation

21 CFR Part 866.3305

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Biphasic Blood Culture Bottle

  Class I

  FDA 510(k) K842036 Active Cleared 1 Jun 1984

• Pediatric Blood Culture Bottles

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  FDA 510(k) K810553 Active Cleared 20 Mar 1981

• Martin-Lewis Agar Medium

  Class II

  FDA 510(k) K770287 Active Cleared 18 Feb 1977

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  FDA 510(k) K864014 Active Cleared 29 Oct 1986

• Gibco Mycotect Kit (Catalog No. 189-5672)

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  FDA 510(k) K860695 Active Cleared 12 Mar 1986

• Haemophilus Isolation Agar 2827

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  FDA 510(k) K841673 Active Cleared 21 May 1984

See all devices from Gibco Laboratories Life Technologies, Inc. →

• What is the purpose of the GIBCO Herpes ID Kit?

  The GIBCO Herpes ID Kit is designed for laboratory use in detecting Herpesvirus Hominis 1,2 through fluorescent antisera, aiding in the identification of herpes virus infections.

• How is the GIBCO Herpes ID Kit supplied?

  The kit is supplied as a Class II medical device manufactured by Gibco Laboratories Life Technologies, Inc. The provided data does not specify whether it is single-use or reusable.

• What regulatory approvals does the GIBCO Herpes ID Kit have?

  The kit has FDA 510(k) clearance K841943, received on May 11, 1984, and decided on March 13, 1985, with a decision description of 'Substantially Equivalent'.

• What is the classification of the GIBCO Herpes ID Kit?

  The kit is classified as a Microbiology device with a product code of GQL and is intended for laboratory use in identifying herpes virus infections through fluorescent antisera.