Immulok Cultureset

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

510(k) Number

K821567 ↗

FDA Product Code

GQL

Device Class

Class II

Regulation

21 CFR Part 866.3305

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Fluoroset Immunofluorescent Antibody

  Class II

  FDA 510(k) K822785 Active Cleared 29 Nov 1982

• Culuture Set Chlamydia Isolation and

  Class I

  FDA 510(k) K830342 Active Cleared 4 May 1983

• Toxoplasma Gondii Antibody Igg

  Class II

  FDA 510(k) K822605 Active Cleared 27 Oct 1982

• Histoset Immunoperoxidase Tissure Kit

  Class I

  FDA 510(k) K820390 Active Cleared 14 Apr 1982

• Flouroset Immunofluorescent Antibody

  Class II

  FDA 510(k) K823055 Active Cleared 5 Nov 1982

• Herpes Simplex Virus Typing Reagents

  Class II

  FDA 510(k) K830971 Active Cleared 30 Jun 1983

See all devices from Immulok, Inc. →

• What is the Immulok Cultureset used for?

  The Immulok Cultureset is a fluorescent antisera diagnostic device specifically designed to detect herpes simplex virus types 1 and 2 (herpesvirus hominis 1,2) in clinical samples. It aids in identifying viral antigens through fluorescent labeling, which enhances visualization under a microscope. This helps trained laboratory personnel accurately diagnose herpes infections in microbiological testing.

• How is the Immulok Cultureset supplied and intended for use?

  The Immulok Cultureset is supplied as a single-use reagent kit. It is intended exclusively for use in laboratory settings by trained personnel. Because it is single-use, reuse is not recommended, and sterility must be maintained during handling to ensure accurate and safe results.

• Is the Immulok Cultureset sterile and how should it be stored?

  Yes, the Immulok Cultureset is sterile as a single-use device. To maintain its efficacy, it must be stored under controlled conditions as specified by the manufacturer. Improper storage conditions could compromise the fluorescent labeling and diagnostic performance of the kit.

• Can the Immulok Cultureset be reused?

  No, the Immulok Cultureset is designed for single-use only. Reuse is not recommended due to potential contamination risks and degradation of the fluorescent antisera, which could lead to inaccurate diagnostic results. Always follow the manufacturer’s instructions for proper handling and disposal.

• What regulatory approval does the Immulok Cultureset hold?

  The Immulok Cultureset holds FDA 510(k) clearance under the classification of a Class II medical device, with the clearance number K821567. This approval is based on a substantial equivalence determination in the microbiology advisory committee category, ensuring compliance with FDA requirements for microbiological diagnostic devices.