K-number	K243345
Device name	Aptima BV Assay; Aptima CV/TV Assay
Applicant	Hologic, Inc.
Product code	PQA
Device class	Class II
Decision date	Nov 25, 2024
Decision	Substantially Equivalent
Regulation	866.3975

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Source

View the full FDA submission: accessdata.fda.gov

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Aptima BV Assay; Aptima CV/TV Assay

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