Data / Medical devices / Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays (PMN): 11 FDA-registered makers in 1 country
11 establishments in 1 country are registered with the FDA to make Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays (product code PMN, Class 2, 21 CFR 866.3920). 6 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 33 510(k) clearances under this code, the latest on October 21, 2026, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PMN
- Device class
- 2
- Regulation
- 866.3920
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 11 |
Makers of Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| 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 October 21, 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.