Hologic, Inc. - FDA 510(k) Cleared Devices

Cleared Sep 25, 2025

Panther Fusion GI Expanded Bacterial Assay

K251993 · PCH

Microbiology · 90d

Cleared Feb 13, 2025

Aptima SARS-CoV-2 Assay

K243396 · QQX

Microbiology · 105d

Cleared Jan 17, 2025

Aptima CMV Quant Assay

K243935 · PAB

Microbiology · 28d

Cleared Nov 25, 2024

Aptima BV Assay

K243345 · PQA

Microbiology · 28d

Cleared Nov 15, 2024

Panther Fusion SARS-CoV-2/Flu A/B/RSV assay

K242465 · QOF

Microbiology · 87d

Cleared Jul 24, 2024

Aptima HCV Quant Dx Assay

K233352 · MZP

Microbiology · 299d

Cleared Jul 18, 2024

Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay

K241240 · QOF

Microbiology · 76d

Cleared Jan 26, 2024

Aptima Neisseria gonorrhoeae Assay

K231329 · LSL

Microbiology · 263d

Cleared Nov 16, 2023

Aptima® Chlamydia trachomatis Assay

K230451 · MKZ

Microbiology · 268d

Cleared Nov 06, 2023

Aptima Trichomonas vaginalis Assay

K231316 · OUY

Microbiology · 182d

Cleared May 16, 2023

Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay

K222736 · QOF

Microbiology · 249d

Cleared May 05, 2023

Panther Fusion AdV/hMPV/RV Assay

K231017 · OCC

Microbiology · 25d