ELVIS HSV ID and D3 Typing Test System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K091753 FDA 510(k)
- FDA Product Code
- GQL 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 ELVIS HSV ID and D3 Typing Test System is a fluorescent antisera-based diagnostic device used for the culture, qualitative identification, and typing of herpes simplex virus (HSV) from cutaneous or mucocutaneous specimens. It aids in distinguishing between HSV type 1 (HSV-1) and HSV type 2 (HSV-2) infections, supporting clinical diagnosis in microbiology settings.
This system is supplied as a kit containing cells, replacement medium, and test reagents for in vitro use. It is classified as a Class 2 device under FDA regulation 866.3305 and was cleared via a Traditional 510(k) pathway (K091753) in 2009. The device is intended for single-use in laboratory environments and requires adherence to standard microbiological practices for handling and storage.
Frequently asked questions
What clinical purpose does the ELVIS HSV ID and D3 Typing Test System serve in a lab setting?
The ELVIS HSV ID and D3 Typing Test System is designed to help microbiologists culture and identify herpes simplex virus (HSV) from skin or mucous membrane samples. It specifically distinguishes between HSV type 1 and HSV type 2, aiding in accurate clinical diagnosis of these infections. This fluorescent antisera-based system supports laboratory workflows by providing qualitative identification and typing of the virus.
Is this device intended for reuse, or is it meant to be used only once?
The ELVIS HSV ID and D3 Typing Test System is explicitly intended for single-use only in laboratory environments. This aligns with standard microbiological practices for diagnostic kits to ensure accuracy, sterility, and patient safety. Reuse is not recommended or supported by the manufacturer.
What components are included in the kit, and how is it supplied?
The kit contains cells, replacement medium, and test reagents—all necessary for in vitro use in identifying and typing HSV. It is supplied as a complete diagnostic system, designed for use in microbiology labs to perform culture and fluorescent antisera-based identification of HSV-1 and HSV-2 from clinical specimens.
How should the device be stored, and are there any special handling requirements?
While the exact storage instructions are not detailed in the provided data, the device is intended for laboratory use and requires adherence to standard microbiological practices for handling and storage. This typically includes maintaining proper temperature, humidity, and contamination control to preserve the integrity of the cells, reagents, and medium included in the kit. Always follow the manufacturer’s included instructions for optimal performance.
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: ELVIS HSV ID AND D3 TYPING TEST SYSTEM - Innolitics, Elvis Hsv Id and D3 Typing Test System - Fda K091753, K971662 - ELVIS HSV ID/TYPING TEST SYSTEM | FDA 510 (k)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K091753 | Class II | Active |
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Manufacturer
- Manufacturer
- Diagnostic Hybrids, Inc.
Sources (1)
- FDA 510(k) K091753 24 fields · synced Sep 19, 2026