K-number	K220924
Device name	Elecsys HSV-2 IgG (08948887160)
Applicant	Roche Diagnostics
Product code	MYF
Device class	Class II
Decision date	Oct 12, 2022
Decision	Substantially Equivalent
Regulation	866.3305

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Source

View the full FDA submission: accessdata.fda.gov

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Elecsys HSV-2 IgG (08948887160)

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