Abbott Molecular, Inc. - FDA 510(k) Cleared Devices
17
Total
16
Cleared
1
Denied
Abbott Molecular, Inc. has 16 FDA 510(k) cleared microbiology devices. Based in Des Plaines, US.
Latest FDA clearance: Sep 2025. Active since 2008.
Browse the complete list of FDA 510(k) cleared microbiology devices from this manufacturer. Filter by specialty or product code using the sidebar.
17 devices
Cleared
Sep 25, 2025
Alinity m HCV
Microbiology
84d
Cleared
Jul 28, 2025
Alinity m EBV (09N43-095)
Microbiology
258d
Cleared
Jul 01, 2025
Alinity m CMV
Microbiology
235d
Cleared
Mar 24, 2025
Alinity m BKV
Microbiology
266d
Cleared
Feb 14, 2025
Alinity m Resp-4-Plex
Microbiology
256d
Cleared
May 03, 2024
Alinity m HSV 1 & 2 / VZV
Microbiology
217d
Cleared
Mar 03, 2023
Alinity m STI Assay
Microbiology
210d
Cleared
Jul 15, 2022
Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No....
Microbiology
317d
Cleared
Apr 29, 2022
Alinity m STI Assay
Microbiology
576d
Cleared
May 09, 2014
ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NG
Microbiology
86d
Cleared
Sep 13, 2013
VYSIS D7S486/CEP 7 FISH PROBE KIT
Pathology
112d
Not Cleared
Jul 29, 2013
VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION)
Pathology
111d
Cleared
Aug 29, 2011
VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721,...
Pathology
789d
Cleared
Aug 09, 2011
VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN)...
Pathology
582d
Cleared
May 28, 2010
ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT,...
Microbiology
267d
Cleared
May 28, 2010
ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02...
Microbiology
267d
Cleared
Jul 10, 2008
ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT
Microbiology
115d