EUROIMMUN LYME ELISA(IgG/IgM)

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K142038 ↗

FDA Product Code

LSR

Device Class

Class II

Regulation

21 CFR Part 866.3830

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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• Euroimmun Anti-Hsv-2 Elisa (Igg) and Anti-Hsv-1 Elisa (Igg) Kit

  Class II

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See all devices from Euroimmun Us Inc. →