Class Class I

Clungene RSV Antigen Rapid Test (K253318)

K253318 2026-01-30 Traditional
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Description

Clungene RSV Antigen Rapid Test by Hangzhou Clongene Biotech Co., Ltd., an FDA 510(k) cleared microbiology device.

Regulatory Information

Device ClassClass Class I
510(k) NumberK253318
Clearance Date2026-01-30
Clearance TypeTraditional
Product CodeGQG
Regulation Number866.3480

Categories

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