Class Class II

ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls (K243575)

K243575 2025-02-12 Traditional
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Description

ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls by Biokit, S.A., an FDA 510(k) cleared microbiology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK243575
Clearance Date2025-02-12
Clearance TypeTraditional
Product CodeMYF
Regulation Number866.3305

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