Skip to the page
Get started – free

Data / Medical devices / United States / Abbott Molecular Distribution Center

Abbott Molecular Distribution Center: FDA-registered device maker in Itasca, IL, United States, 8 510(k) clearances and 7 PMA approvals

Abbott Molecular Distribution Center is registered with the FDA (registration 3019837962) in Itasca, IL, United States. It lists 28 device types. The FDA files 8 510(k) clearances and 7 PMA approvals under its listings, the newest dated February 14, 2025. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Abbott Molecular Distribution Center
FDA registration number
3019837962
Address
1015 West Devon, Itasca, IL, United States, 60143
Owner or operator
ABBOTT LABORATORIES (1415939)
Roles
Manufacturer, Manufacturer for export
First device listed
June 30, 1998
Registered through
2027
Brand names listed
20X SSC, 500g, AMP Check E GPR, Abbott Bisulfite Modification Kit, Abbott Bulk Universal Collection Kit (List 09N92-010), Abbott MultiCollect Specimen Collection Kit 09K12, Abbott Proteinase K, Abbott Real Time CT/NG Amplification Reagent Extended Use Including UNG (08L07-067), Abbott RealTime CMV Amplification Reagent Kit (5N23-90) and more

Devices it lists

DeviceProduct codeClassRoleSource
Assay, Genotyping, Hepatitis C VirusOBF2Manufacturer for exportaccessdata.fda.gov
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C VirusMZP2Manufacturer, Manufacturer for exportaccessdata.fda.gov
Clinical Sample ConcentratorJJH1Manufacturer for exportaccessdata.fda.gov
Cytomegalovirus (Cmv) Dna Quantitative AssayPAB2Manufacturer, Manufacturer for exportaccessdata.fda.gov
Device, Specimen CollectionLIO1Manufacturer, Manufacturer for exportaccessdata.fda.gov
Dna Fish Probe Kit For Specimen Characterization, Human Chromosome, Hematological DisordersPFG2Manufactureraccessdata.fda.gov
Dna Probe, Nucleic Acid Amplification, ChlamydiaMKZ1Manufactureraccessdata.fda.gov
Dna-Probe Kit, Human ChromosomeOYU2Manufacturer, Manufacturer for exportaccessdata.fda.gov
Dna-Reagents, Epstein-Barr VirusLSF1Manufacturer for exportaccessdata.fda.gov
Dna-Reagents, NeisseriaLSL2Manufacturer, Manufacturer for exportaccessdata.fda.gov
Early Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen CharacterizationPDO2Manufactureraccessdata.fda.gov
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseLXG1Manufacturer for exportaccessdata.fda.gov
Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene RearrangementOWE2Manufactureraccessdata.fda.gov
Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)PNK2Manufactureraccessdata.fda.gov
General Purpose ReagentPPM1Manufactureraccessdata.fda.gov
Hepatitis Viral B Dna DetectionMKT2Manufacturer for exportaccessdata.fda.gov
Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion SamplesPGI2Manufacturer for exportaccessdata.fda.gov
Human Immunodeficiency Virus (Hiv) Viral Load Monitoring TestQUM2Manufactureraccessdata.fda.gov
Kit, Dna Detection, Human PapillomavirusMAQ3Manufacturer, Manufacturer for exportaccessdata.fda.gov
Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial AgentsQOF2Manufactureraccessdata.fda.gov
Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) DnaQMI2Manufacturer for exportaccessdata.fda.gov
Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted InfectionsQEP2Manufactureraccessdata.fda.gov
Reagents, 2019-Novel Coronavirus Nucleic AcidQJRNManufactureraccessdata.fda.gov
Real Time Nucleic Acid Amplification SystemOOI2Manufactureraccessdata.fda.gov
Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For RecurrenceNSD3Manufactureraccessdata.fda.gov
Test, Hiv DetectionMZF2Manufacturer for exportaccessdata.fda.gov
Trichomonas Vaginalis Nucleic Acid Amplification Test SystemOUY2Manufacturer, Manufacturer for exportaccessdata.fda.gov
Urine Transport Kit (Excludes Hiv Testing)OHZ1Manufacturer for exportaccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
February 14, 2025K241573Alinity m Resp-4-PlexQOFSubstantially EquivalentAbbott Molecular, Inc.accessdata.fda.gov
March 3, 2023K222379Alinity m STI AssayQEPSubstantially EquivalentAbbott Molecular, Inc.accessdata.fda.gov
April 29, 2022K202977Alinity m STI AssayQEPSubstantially EquivalentAbbott Molecular, Inc.accessdata.fda.gov
May 9, 2014K140354ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NGLSLSubstantially EquivalentAbbott Molecular, Inc.accessdata.fda.gov
September 13, 2013K131508VYSIS D7S486/CEP 7 FISH PROBE KITPFGSubstantially EquivalentAbbott Molecular, Inc.accessdata.fda.gov
July 29, 2013DEN130010VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION)PDOUnknownAbbott Molecular, Inc.accessdata.fda.gov
July 10, 2008K080739ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KITMKZSubstantially EquivalentAbbott Molecular, Inc.accessdata.fda.gov
April 13, 2001K010288ANEUVYSION MULITICOLOR DNA PROBE KITOYUSubstantially EquivalentVysisaccessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
November 1, 2023P230003Alinity m HR HPVMAQ19September 2, 2026accessdata.fda.gov
May 5, 2022P210022Alinity m CMVPAB12September 13, 2024accessdata.fda.gov
March 23, 2020P190025Alinity m HCVMZP6June 1, 2021accessdata.fda.gov
May 18, 2017P160044ABBOTT REALTIME CMVPAB5January 13, 2023accessdata.fda.gov
April 11, 2016P150041VYSIS CLL FISH PROBE KITPNK8February 18, 2026accessdata.fda.gov
August 26, 2011P110012VYSIS ALK BREAK APART FISH PROBE KIT, VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT PROBECHEK ALKOWE23February 18, 2026accessdata.fda.gov
January 24, 2005P030052UROVYSION BLADDER CANCER KIT30February 18, 2026accessdata.fda.gov

Compare with other makers

Updated September 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.