Herpes Simplex Group Cf Antigen

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

510(k) Number

K850609 ↗

FDA Product Code

GQN

Device Class

Class II

Regulation

21 CFR Part 866.3305

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Herpes-Iha Kit

  Class I

  FDA 510(k) K822095 Active Cleared 5 Apr 1983

• Cmv Cf Antigen

  Class II

  FDA 510(k) K853277 Active Cleared 7 Nov 1985

• Mycoplasma Pneumoniae Cf Antigen

  Class I

  FDA 510(k) K834338 Active Cleared 27 Feb 1984

• Chlamydia Group Cf Antigen

  Class I

  FDA 510(k) K844868 Active Cleared 5 Mar 1985

• Arbovirus Igm Ifa Test

  Class I

  FDA 510(k) K913618 Active Cleared 3 Dec 1992

• Polio Type I Cf Antigen, & Type II, III

  Class I

  FDA 510(k) K853278 Active Cleared 7 Nov 1985

See all devices from Hillcrest Biologicals →

• What is the Herpes Simplex Group Cf Antigen used for?

  The Herpes Simplex Group Cf Antigen is used in serological tests to identify antibodies to herpes simplex virus in serum. It serves as a reagent that detects immune response to HSV-1 and HSV-2 by binding to patient antibodies in assay formats.

• How is the Herpes Simplex Group Cf Antigen supplied and what is its format?

  The device is supplied as part of serological assays that may include antigens and antisera. It is provided as an antigen reagent intended for use in laboratory-based antibody detection tests, not as a standalone test kit.

• Is the Herpes Simplex Group Cf Antigen a single-use or reusable device?

  As an antigen reagent used in serological testing, the Herpes Simplex Group Cf Antigen is intended for single-use in each test procedure. Reuse is not recommended due to potential degradation, contamination, or loss of reactivity that could compromise test accuracy.

• What regulatory pathway was used for the Herpes Simplex Group Cf Antigen and when was it cleared?

  The device received FDA 510(k) clearance through the Traditional pathway on May 9, 1985, under submission K850609. It was found substantially equivalent to a predicate device, which is the basis for its market authorization.

• Who manufactures the Herpes Simplex Group Cf Antigen and where is it produced?

  The Herpes Simplex Group Cf Antigen is manufactured by Hillcrest Biologicals, located at 10703 Progress Way, Cypress, California, 90630, United States. This address is registered in the FDA’s device listing and establishment records.