SeroCard HSV IgG Antibody Test Kit

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K903070 ↗

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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• Modified Ddi Serocard Toxoplasma Igg Test Kit

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• Immunocard Hcg II-S Test Kit

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• Modified Ddi Serocard Cmv Igg Test Kit

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• Immunocard Strep a Test

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  FDA 510(k) K896109 Active Cleared 29 Nov 1989

• Modified Ddi Serocard Rubella Igg Test Kit

  Class II

  FDA 510(k) K884247 Active Cleared 10 Apr 1989

See all devices from Disease Detection International, Inc. →

• What is the SeroCard HSV IgG Antibody Test Kit used for in a clinical setting?

  The SeroCard HSV IgG Antibody Test Kit is designed as an in vitro diagnostic tool using ELISA technology to qualitatively detect IgG antibodies against herpes simplex virus (HSV). It helps laboratories identify past HSV infections by measuring specific antibody responses in patient serum or plasma samples, aiding in immunology testing.

• Is the SeroCard HSV IgG Antibody Test Kit intended for single-use or reusable applications?

  The kit is explicitly labeled as a single-use diagnostic tool and is not intended for reuse. This ensures patient safety and maintains the accuracy of test results, as reusing the device could compromise sterility and performance.

• What type of storage conditions are required for the SeroCard HSV IgG Antibody Test Kit?

  The kit does not require special storage conditions beyond those outlined in the accompanying instructions. This means it can be stored under standard laboratory conditions, though proper handling and environmental controls (e.g., temperature, humidity) should still be followed to preserve its integrity.

• How is the regulatory status of the SeroCard HSV IgG Antibody Test Kit determined?

  The device holds FDA 510(k) clearance (K903070) and is classified as substantially equivalent to predicate devices. This means its safety and performance were reviewed by the FDA and deemed comparable to previously approved similar products, ensuring it meets regulatory standards for laboratory use in immunology testing.

• Is the SeroCard HSV IgG Antibody Test Kit sterile, and where is it intended for use?

  The kit is non-sterile and is specifically intended for use in clinical microbiology laboratories. Its non-sterile nature is accounted for in its design as a single-use diagnostic tool, where contamination risks are managed through proper laboratory protocols.