Class Class II

Elecsys Anti-SARS-CoV-2 (K253839)

K253839 2025-12-17 Special
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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) NumberK253839
Clearance Date2025-12-17
Clearance TypeSpecial
Product CodeQVP
Regulation Number866.3983

Categories

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