Data / Medical devices / Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays / United States
FDA-registered makers of Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays in the United States: 11 establishments
11 establishments in the United States are registered with the FDA to make Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays (product code PMN). 6 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
- Product code
- PMN
- Country
- United States
Makers of Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Maine Molecular Quality Controls, Inc. | Saco, ME, United States | Manufacturer | 9 | May 19, 2026 | 0 | 0 | 0 | api.fda.gov |
| Microbiologics, Inc. | Saint Cloud, MN, United States | Manufacturer | 6 | October 7, 2019 | 0 | 3 | 0 | api.fda.gov |
| Streck LLC | La Vista, NE, United States | Manufacturer | 3 | July 27, 2023 | 0 | 0 | 0 | api.fda.gov |
| Bio-Rad Laboratories Inc. | Irvine, CA, United States | Manufacturer | 1 | March 28, 2016 | 0 | 0 | 0 | api.fda.gov |
| Bio-Rad Laboratories Inc. | Irvine, CA, United States | Manufacturer | 1 | March 28, 2016 | 0 | 0 | 0 | api.fda.gov |
| BioFire Defense, LLC | Salt Lake City, UT, United States | Manufacturer | 1 | November 20, 2020 | 0 | 0 | 0 | api.fda.gov |
| Autonomous Medical Devices Incorporated | Santa Ana, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DiaSorin Molecular LLC | Cypress, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hologic, Inc. | San Diego, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ortho-Clinical Diagnostics, Inc. | Athens, OH, United States | Manufacturer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quidel Corp. | San Diego, CA, United States | Manufacturer, Manufacturer for export | 0 | 0 | 0 | 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.