Antibody to Herpesvirus Hominis

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

510(k) Number

K791058 ↗

FDA Product Code

GQO

Device Class

Class II

Regulation

21 CFR Part 866.3305

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Lipase Hydrolysis/Glycerol Kinase, Triglycerides

  Class I

  FDA 510(k) K863874 Active Cleared 13 Nov 1986

• Toxoplasma Gondii Igg Elisa

  Class II

  FDA 510(k) K871905 Active Cleared 30 Jul 1987

• Gemeni Igm Assay

  Class II

  FDA 510(k) K800450 Active Cleared 24 Apr 1980

• Herpes Ident. & Typing Test Hitt

  Class II

  FDA 510(k) K831504 Active Cleared 20 Sep 1983

• Gemeni Igg Assay

  Class II

  FDA 510(k) K800451 Active Cleared 24 Apr 1980

• Gemstar System

  Class I

  FDA 510(k) K821335 Active Cleared 13 Jul 1982

See all devices from Electro-Nucleonics Laboratories, Inc. →

• What is the Antibody to Herpesvirus Hominis used for in a clinical setting?

  This device is an antisera reagent used exclusively in laboratory settings to detect antibodies against Herpesvirus hominis (types 1 and 2) in patient serum samples. It functions as part of serological assays to help identify potential herpes simplex virus infections, aiding in diagnostic testing for microbiologists.

• Is this product intended for single-use or repeated use?

  The Antibody to Herpesvirus Hominis is explicitly designed for single-use applications in microbiology laboratories. It is not meant to be reused after opening or initial use.

• How is this diagnostic reagent supplied, and where would it be used?

  This product is supplied for in vitro use in microbiology laboratories. It is intended for laboratory testing only and is not meant for direct patient administration or use outside controlled diagnostic settings.

• What regulatory pathway was followed for this device, and what does that mean for its use?

  The Antibody to Herpesvirus Hominis received FDA 510(k) clearance under the Traditional pathway in 1979, with a determination of Substantially Equivalent (SESE) by the Microbiology Advisory Committee. This means it was evaluated against a legally marketed predicate device and found to have the same intended use and technological characteristics, ensuring its compliance with FDA standards for diagnostic reagents in microbiology.

• Are there any specific storage instructions provided for this product?

  The regulatory data does not specify detailed storage conditions beyond standard laboratory practices for diagnostic reagents. Laboratories should follow general guidelines for storing antisera, such as maintaining appropriate temperature and avoiding contamination, though exact instructions would typically be found in the product’s accompanying documentation.