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D3 DFA Herpes Simplex Virus Identification and Typing Kit, Model 01-090000

FDA 510(k)

Class II (US FDA 510(k))

510(k) K070265

by Diagnostic Hybrids, Inc.

Identifiers

510(k) Number
K070265 FDA 510(k)
FDA Product Code
GQN FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.3305 FDA 510(k)
Regulation Number
866.3305 FDA 510(k)
Advisory Committee
Microbiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The D3 DFA Herpes Simplex Virus Identification and Typing Kit is a diagnostic in vitro device classified as an Antigen, Cf (Including Cf Control), Herpesvirus hominis 1,2 under FDA regulation 866.3305. It employs fluoresceinated monoclonal antibodies to enable the qualitative detection and differentiation of human herpes simplex virus types 1 and 2 (HSV-1 and HSV-2) in cell cultures via immunofluorescence. The kit facilitates rapid identification of viral antigens, aiding in laboratory diagnostics for herpes simplex infections. Its design relies on type-specific murine monoclonal antibodies to enhance accuracy in typing HSV strains.

This kit is intended for use in microbiology laboratories and requires trained personnel to perform immunofluorescence assays. Supplied as a single-use reagent system, it includes necessary controls and reagents for testing. The device is not sterile and must be handled in accordance with standard laboratory practices for infectious agents. Authorized for use in the United States under FDA 510(k) clearance (K070265), it adheres to microbiology classification standards and is distributed for research and diagnostic purposes only. Storage conditions and expiration dates are specified on the packaging.

Frequently asked questions

What is the D3 DFA Herpes Simplex Virus Identification and Typing Kit used for?

This kit is designed for the qualitative detection and differentiation of human herpes simplex virus types 1 and 2 (HSV-1 and HSV-2) in cell cultures. It employs fluoresceinated monoclonal antibodies to identify viral antigens via immunofluorescence, aiding in accurate HSV strain typing for laboratory diagnostics.

How is the D3 DFA Herpes Simplex Virus Identification and Typing Kit supplied?

The kit is supplied as a single-use reagent system, including all necessary controls and reagents for performing immunofluorescence assays. It is intended for use in microbiology laboratories by trained personnel.

Is the D3 DFA Herpes Simplex Virus Identification and Typing Kit sterile?

No, the kit is not sterile. It must be handled according to standard laboratory practices for infectious agents, as it is designed for use with cell cultures containing potential pathogens.

Can the D3 DFA Herpes Simplex Virus Identification and Typing Kit be reused?

No, the kit is intended for single-use only. Each kit is a complete reagent system, and reuse is not recommended or supported by the manufacturer.

What storage conditions should be followed for the D3 DFA Herpes Simplex Virus Identification and Typing Kit?

Storage conditions and expiration dates are specified on the packaging. The kit should be stored as directed to maintain its integrity and performance, typically in a controlled environment to prevent degradation.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: D³™ DFA HSV Identification and Typing Kit | QuidelOrtho, Diagnostic Hybrids' D3 Dfa Herpes Simplex Virus Identification and ..., D³™ DFA HSV Identification Kit | QuidelOrtho

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Diagnostic Hybrids, Inc.

Sources (1)

  • FDA 510(k) K070265 24 fields · synced Oct 1, 2026