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The EUROIMMUN Anti-HSV-1 ELISA (IgG) is intended for the qualitative determination of IgG class antibodies against Herpes simplex virus type 1 (HSV-1) specific glycoprotein C1 in human serum. It is intended for the presumptive diagnosis of type specific HSV-1 infection with EUROIMMUN Anti-HSV-2 EUSA (IgG) in persons suspected of herpes viral infection.

The EUROIMMUN Anti-HSV-2 ELISA (IgG) is intended for the qualitative determination of IgG class antibodies against herpes simplex virus type 2 (HSV-2) specific glycoprotein G2 in human serum. It is intended for the presumptive diagnosis of type specific HSV-2 infection with EUROIMMUN Anti-HSV-1 EUSA (lgG) in persons suspected of herpes viral infection.

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This document is a 510(k) premarket notification decision letter from the FDA for the EUROIMMUN Anti-HSV-1 ELISA (IgG) Kit and EUROIMMUN Anti-HSV-2 ELISA (IgG) Kit. It primarily focuses on the FDA's determination of substantial equivalence to previously marketed devices. While it states the intended use of the devices, it does not contain detailed information about the acceptance criteria and study proving the device meets those criteria.

Therefore, I cannot provide the requested information based on the input text. The document is a regulatory approval letter, not a study report.

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