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

Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections

Hologic, Inc.

The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for 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.

Pre-market Notification Details

Device IDK220321
510k NumberK220321
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
ClassificationNucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections
Applicant Hologic, Inc. 10210 Genetic Center Drive San Diego,  CA  92121
ContactJill Wyland
CorrespondentJill Wyland
Hologic, Inc. 10210 Genetic Center Drive San Diego,  CA  92121
Product CodeQEP  
Subsequent Product CodeLSL
Subsequent Product CodeMKZ
Subsequent Product CodeOUY
CFR Regulation Number866.3393 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-02-03
Decision Date2022-06-03

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