Data / Medical devices / Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test (NJR): 12 FDA-registered makers in 4 countries
12 establishments in 4 countries are registered with the FDA to make Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test (product code NJR, Class 1, 21 CFR 866.3740). 7 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 18 510(k) clearances under this code, the latest on September 27, 2023, and lists 11 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- NJR
- Device class
- 1
- Regulation
- 866.3740
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
| Canada | 2 |
| China | 2 |
| Sweden | 1 |
Makers of Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
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 |
|---|---|---|---|---|---|---|---|---|
| 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 |
| GeneOhm Sciences Canada, ULC. | Quebec, Canada | Manufacturer | 1 | February 16, 2012 | 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 |
| Cepheid AB | SOLNA Stockholm, Sweden | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hologic, Inc. | San Diego, CA, United States | Manufacturer | 0 | 0 | 2 | 0 | api.fda.gov | |
| Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. | Nantong Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Meridian Bioscience Canada Inc. | Quebec, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Tianlong Biotechnology Co., Ltd. | Suzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 27, 2023. 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.