Abbott Molecular, Inc. - FDA 510(k) Cleared Devices

Cleared Sep 25, 2025

Alinity m HCV

K252102 · MZP

Microbiology · 84d

Cleared Jul 28, 2025

Alinity m EBV (09N43-095)

K243489 · QLX

Microbiology · 258d

Cleared Jul 01, 2025

Alinity m CMV

K243485 · PAB

Microbiology · 235d

Cleared Mar 24, 2025

Alinity m BKV

K241921 · QMI

Microbiology · 266d

Cleared Feb 14, 2025

Alinity m Resp-4-Plex

K241573 · QOF

Microbiology · 256d

Cleared May 03, 2024

Alinity m HSV 1 & 2 / VZV

K233349 · PGI

Microbiology · 217d

Cleared Mar 03, 2023

Alinity m STI Assay

K222379 · QEP

Microbiology · 210d

Cleared Jul 15, 2022

Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No....

K212778 · QLX

Microbiology · 317d

Cleared Apr 29, 2022

Alinity m STI Assay

K202977 · QEP

Microbiology · 576d

Cleared May 09, 2014

ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NG

K140354 · LSL

Microbiology · 86d

Cleared May 28, 2010

ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT,...

K092704 · LSK

Microbiology · 267d

Cleared May 28, 2010

ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02...

K092705 · OOI

Microbiology · 267d