Class Class II

Elecsys Anti-SARS-CoV-2 (K250768)

K250768 2025-06-10 Traditional
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Description

Elecsys Anti-SARS-CoV-2 by Roche Diagnostics, an FDA 510(k) cleared microbiology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK250768
Clearance Date2025-06-10
Clearance TypeTraditional
Product CodeQVP
Regulation Number866.3983

Categories

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