Name: Predicase
Price: 199 USD

K-number	K220321
Device name	Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test kit) Tigris, Aptima Trichomonas Vaginalis Assay (250 test kit) Panther, Aptima Trichomonas Vaginalis Assay (250 test kit) Tigris
Applicant	Hologic, Inc.
Product code	QEP
Device class	Class II
Decision date	Jun 3, 2022
Decision	Substantially Equivalent
Regulation	866.3393

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Source

View the full FDA submission: accessdata.fda.gov

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Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test kit) Tigris, Aptima Trichomonas Vaginalis Assay (250 test kit) Panther, Aptima Trichomonas Vaginalis Assay (250 test kit) Tigris

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