FDA.reportPublic FDA data

Device Listing 1110591424

Listing Summary#

Listing key
1110591424
Premarket submission
K243575
Device
ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls
Applicant
Biokit, S.A.
Product code
MYF
Decision date
2025-02-12