Identifiers
- 510(k) Number
- K891162 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 HSV-1 ELISA Test System is a laboratory device used for the detection of antibodies to Herpes Simplex Virus Type 1. This test system is designed for in vitro diagnostic use to aid in the diagnosis of HSV-1 infections by detecting specific antibodies in patient serum samples.
The device is supplied as a test system for laboratory use and is not intended for home use. It is a single-use device and requires appropriate storage conditions as specified by the manufacturer. The HSV-1 ELISA Test System has received FDA 510(k) clearance with the product code GQL and is classified as Class II under regulation number 866.3305.
Frequently asked questions
What is the HSV-1 ELISA Test System used for?
The HSV-1 ELISA Test System is a laboratory device designed for in vitro diagnostic use to aid in the diagnosis of HSV-1 infections by detecting specific antibodies in patient serum samples.
Is the HSV-1 ELISA Test System reusable or single-use?
The HSV-1 ELISA Test System is a single-use device and is not intended for home use. It requires appropriate storage conditions as specified by the manufacturer.
What regulatory approvals does the HSV-1 ELISA Test System have?
The HSV-1 ELISA Test System has received FDA 510(k) clearance with the product code GQL and is classified as Class II under regulation number 866.3305.
How is the HSV-1 ELISA Test System supplied?
The device is supplied as a test system specifically for laboratory use. It is not intended for home use and requires appropriate storage conditions as specified by the manufacturer.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K891162 | Class II | Active |
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Manufacturer
- Manufacturer
- Zeus Scientific, Inc.
Sources (1)
- FDA 510(k) K891162 24 fields · synced Sep 23, 2026