Data / Medical devices / Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test / United States
FDA-registered makers of Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test in the United States: 7 establishments
7 establishments in the United States are registered with the FDA to make Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test (product code NJR). 6 have a 510(k) clearance or PMA approval on file and 4 have a recall event. FDA data exported November 3, 2026.
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- Device
- Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
- Product code
- NJR
- Country
- United States
Makers of Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Cepheid | Sunnyvale, CA, United States | Manufacturer, Manufacturer for export, Specification developer | 5 | September 27, 2023 | 0 | 2 | 0 | api.fda.gov |
| Cepheid | Lodi, CA, United States | Manufacturer | 5 | September 27, 2023 | 0 | 0 | 0 | api.fda.gov |
| Meridian Bioscience, Inc. | Cincinnati, OH, United States | Manufacturer | 2 | May 25, 2017 | 0 | 1 | 0 | api.fda.gov |
| Becton, Dickinson & Co. | Sparks, MD, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | February 16, 2012 | 0 | 4 | 0 | api.fda.gov |
| DiaSorin Molecular LLC | Cypress, CA, United States | Manufacturer, Manufacturer for export | 1 | November 7, 2018 | 0 | 0 | 0 | api.fda.gov |
| Ortho-Clinical Diagnostics, Inc. | Athens, OH, United States | Complaint file establishment, Manufacturer | 1 | December 21, 2017 | 0 | 0 | 0 | api.fda.gov |
| Hologic, Inc. | San Diego, CA, United States | Manufacturer | 0 | 0 | 2 | 0 | api.fda.gov |
Updated November 3, 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.