H. Simplex Virus

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

510(k) Number

K843658 ↗

FDA Product Code

GQN

FDA applicant

Institute Virion , Ltd.

Device Class

Class II

Regulation

21 CFR Part 866.3305

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Chlamydia

  Class I

  FDA 510(k) K843654 Active Cleared 8 Aug 1985

• Influenza A2 Virus

  Class I

  FDA 510(k) K843659 Active Cleared 26 Sep 1985

• Adenovirus

  Class I

  FDA 510(k) K843649 Active Cleared 26 Sep 1985

• In Fluenza B Virus

  Class I

  FDA 510(k) K843660 Active Cleared 26 Sep 1985

• Mycoplasma Pneumoniae

  Class I

  FDA 510(k) K843664 Active Cleared 25 Oct 1984

• Measles Virus Rubeola

  Class I

  FDA 510(k) K843662 Active Cleared 26 Sep 1985

See all devices from Institute Virion, Ltd. →

• What is the H. Simplex Virus antigen test used for?

  The H. Simplex Virus antigen test is designed to detect the presence of Herpesvirus Hominis 1 and 2 (HSV-1,2) in clinical samples. It is a microbiology device used primarily for identifying these viruses in laboratory settings, aiding in the diagnosis of herpes infections.

• How is the H. Simplex Virus antigen test supplied?

  The test is supplied by Institute Virion, Ltd. and is available as a Class 2 medical device under the product code GQN. It is regulated under FDA regulation number 866.3305 and falls under the microbiology specialty category.

• Is the H. Simplex Virus antigen test single-use or reusable?

  The device is classified as a single-use antigen test, as implied by its design for detecting viral antigens in clinical samples. Single-use devices are intended for one-time use per patient sample to ensure accuracy and prevent cross-contamination.

• What regulatory approval does the H. Simplex Virus antigen test hold?

  The H. Simplex Virus antigen test received FDA 510(k) clearance on September 26, 1985, under the decision code SESE (Substantially Equivalent). This clearance indicates that the device is considered substantially equivalent to a legally marketed predicate device.

• Where can I find more details about the H. Simplex Virus antigen test’s specifications?

  For detailed specifications, including the device’s classification, regulatory number (866.3305), and product code (GQN), refer to the FDA’s OpenFDA database or the manufacturer’s documentation. The test is categorized under microbiology and is intended for use in clinical laboratories.