Data / Medical devices / Device, General Purpose, Microbiology, Diagnostic / United States

FDA-registered makers of Device, General Purpose, Microbiology, Diagnostic in the United States: 21 establishments

Name: FDA-registered makers of Device, General Purpose, Microbiology, Diagnostic in the United States
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

21 establishments in the United States are registered with the FDA to make Device, General Purpose, Microbiology, Diagnostic (product code LIB). 0 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.

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Device: Device, General Purpose, Microbiology, Diagnostic
Product code: LIB
Country: United States

Makers of Device, General Purpose, Microbiology, Diagnostic in the United States

Maker	Location	Role	Recall events	Source
Aceso Laboratories Inc.	Chino, CA, United States	Manufacturer	0	api.fda.gov
Auer 2260	Mesa, AZ, United States	Contract manufacturer	0	api.fda.gov
Abbott Diagnostics Scarborough, Inc.	Scarborough, ME, United States	Manufacturer for export	0	api.fda.gov
Becton, Dickinson & Co.	Sparks, MD, United States	Complaint file establishment, Specification developer	1	api.fda.gov
Beckman Coulter, Inc.	West Sacramento, CA, United States	Manufacturer, Specification developer	0	api.fda.gov
Casco Manufacturing Solutions, Inc.	Cincinnati, OH, United States	Manufacturer	0	api.fda.gov
Chatmd	Plymouth, IN, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Caplugs, Inc.	Rancho Dominguez, CA, United States	Manufacturer	0	api.fda.gov
Carclo Technical Plastics - Latrobe	Latrobe, PA, United States	Contract manufacturer	0	api.fda.gov
DiaSorin Molecular LLC	Cypress, CA, United States	Manufacturer	0	api.fda.gov
Diagnostic Automation/ Cortez Diagnostics Inc,.	Woodland Hills, CA, United States	Manufacturer for export	0	api.fda.gov
Eiger Diagnostics, Inc.	Las Vegas, NV, United States	Manufacturer for export	0	api.fda.gov
Hardy Diagnostics	Orcutt, CA, United States	Manufacturer	0	api.fda.gov
Intl. Medsurg Connection, Inc.	Schaumburg, IL, United States	Specification developer	0	api.fda.gov
Microbiologics, Inc.	Saint Cloud, MN, United States	Manufacturer	0	api.fda.gov
New Life Diagnostics Inc.	Carlsbad, CA, United States	Manufacturer for export	0	api.fda.gov
Parter Medical Products, Inc.	Carson, CA, United States	Manufacturer	0	api.fda.gov
Plastikon Industries	Hayward, CA, United States	Contract manufacturer	0	api.fda.gov
Remel, Inc.	Lenexa, KS, United States	Manufacturer, Specification developer	3	api.fda.gov
Sio2 Medical Products, LLC	Auburn, AL, United States	Manufacturer	0	api.fda.gov
Typenex Medical, LLC	Chicago, IL, United States	Complaint file establishment, Specification developer	0	api.fda.gov

Updated November 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.