Immulite Herpes I and II Igg

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

510(k) Number

K950670 ↗

FDA Product Code

LGC

Device Class

Class II

Regulation

21 CFR Part 866.3305

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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  Class II

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• Coat-A-Count T4 Ria Kit

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• Immulite 2000 Digoxin, Models L2KDI2 (200 Tests) and L2KDI6 (600 Tests)

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• Coat-A-Count Direct Androstenedione

  Class I

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• What is the Immulite Herpes I and II IgG assay used for?

  The Immulite Herpes I and II IgG is an enzyme linked immunoabsorbent assay designed to detect and quantify IgG antibodies specific to Herpes Simplex Virus types I and II in patient samples, aiding in the diagnosis of herpes infections.

• How is the Immulite Herpes I and II IgG assay supplied?

  The device is supplied as a laboratory test kit intended for in vitro diagnostic use. The kit contains all necessary components for performing the immunoassay to detect herpes antibodies in patient samples.

• What is the regulatory classification of the Immulite Herpes I and II IgG assay?

  The device has FDA 510(k) clearance with product code LGC and is classified as a Class II medical device. It received traditional clearance through the Microbiology advisory committee in 1996.

• Is the Immulite Herpes I and II IgG assay single-use or reusable?

  The device description does not specify whether it is single-use or reusable. As a laboratory test kit, it may contain components that are used once per test while other elements of the system might be reusable according to standard laboratory protocols.