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Hsv-1 And/Or -2 Igm Elisa Test System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K983656

by Zeus Scientific, Inc.

Identifiers

510(k) Number
K983656 FDA 510(k)
FDA Product Code
LGC 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 and HSV-2 IgM ELISA Test System is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgM class antibodies to Herpes Simplex Virus types 1 and 2 in human serum. This diagnostic tool aids in identifying serologic evidence of primary or reactivated HSV infections by measuring specific antibody responses. It falls under the category of non-specific HSV enzyme immunoassays, adhering to microbiological testing standards. The system leverages immunoassay technology to provide rapid and sensitive results for clinical evaluation.

This test system is intended for in vitro diagnostic use in clinical laboratory settings. It is supplied as a ready-to-use kit and requires no additional sterilization, as it is designed for single-use per test. The device is classified under FDA’s device class 2 and has received a 510(k) clearance through a traditional review pathway, with the advisory committee classification in microbiology. Storage and handling follow standard laboratory protocols for immunoassay reagents, ensuring stability and accuracy of results.

Frequently asked questions

What is the HSV-1 and HSV-2 IgM ELISA Test System used for?

This test system detects IgM class antibodies to Herpes Simplex Virus types 1 and 2 in human serum. IgM antibodies indicate recent or primary HSV infections, or reactivation, helping clinicians assess acute infection status. It is specifically designed for qualitative in vitro diagnostic use in clinical laboratories.

How is the HSV-1 and HSV-2 IgM ELISA Test System supplied?

The kit is supplied as a ready-to-use system, meaning no additional preparation or sterilization is required before use. Each test is intended for single-use only, ensuring accuracy and preventing cross-contamination.

Is the HSV-1 and HSV-2 IgM ELISA Test System sterile?

The test system is not labeled as requiring sterilization, as it is designed for single-use per test. However, standard laboratory protocols for handling immunoassay reagents should be followed to maintain sterility and reliability of results.

What storage and handling guidelines apply to this test system?

Storage and handling follow standard laboratory protocols for immunoassay reagents. This ensures the stability and accuracy of the test results. The manufacturer’s instructions should be consulted for specific storage conditions, such as temperature and shelf life.

Is this test system reusable or single-use?

The HSV-1 and HSV-2 IgM ELISA Test System is explicitly designed for single-use per test. This design minimizes the risk of contamination and ensures consistent, reliable results for each individual test.

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: HSV-1 & 2 IgM Test System - ZEUS Scientific, PDF HSV-1 & 2 IgM Test System - Zeus Scientific, Inc, AccessGUDID - DEVICE: ELISA HSV-1 & 2 IgM Smart Kit Test System ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Zeus Scientific, Inc.

Sources (1)

  • FDA 510(k) K983656 24 fields · synced Oct 1, 2026