Rsv Ifa Test Kit for Direct Antigen Detection

No FDA recalls on record, checked 10 Oct 2026.

510(k) Number

K884192 ↗

FDA Product Code

LKT

Device Class

Class I

Regulation

21 CFR Part 866.3480

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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• Bartels Herpes Simplex Virus 2 Igg Eia

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• Dried Gram Negative/Cefmetazole

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