Data / Medical devices / Microbial Nucleic Acid Storage And Stabilization Device
Microbial Nucleic Acid Storage And Stabilization Device (QBD): 23 FDA-registered makers in 6 countries
23 establishments in 6 countries are registered with the FDA to make Microbial Nucleic Acid Storage And Stabilization Device (product code QBD, Class 2, 21 CFR 866.2950). 12 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 17 510(k) clearances under this code, the latest on May 27, 2025, and lists 5 recall events (2 Class I). FDA data exported November 2, 2026.
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- Product code
- QBD
- Device class
- 2
- Regulation
- 866.2950
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 15 |
| China | 4 |
| Italy | 1 |
| Belgium | 1 |
| Brazil | 1 |
| Sweden | 1 |
Makers of Microbial Nucleic Acid Storage And Stabilization Device
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 |
|---|---|---|---|---|---|---|---|---|
| Blue Life Solutions, LLC. | Las Vegas, NV, United States | Manufacturer, Repackager or relabeler | 2 | September 28, 2023 | 0 | 0 | 0 | api.fda.gov |
| Copan Italia | BRESCIA Lombardy, Italy | Contract manufacturer, Manufacturer | 1 | September 17, 2020 | 0 | 0 | 0 | api.fda.gov |
| Fertipro N.V. | BEERNEM West-Vlaanderen, Belgium | Manufacturer | 1 | June 11, 2024 | 0 | 0 | 0 | api.fda.gov |
| Hangzhou Bioer Technology Co., Ltd | Hangzhou Zhejiang, China | Manufacturer | 1 | June 26, 2024 | 0 | 0 | 0 | api.fda.gov |
| Longhorn Vaccines and Diagnostics LLC | Bethesda, MD, United States | Complaint file establishment, Specification developer | 1 | March 19, 2018 | 0 | 1 | 0 | api.fda.gov |
| Magbio Genomics Inc. | Gaithersburg, MD, United States | Specification developer | 1 | July 28, 2022 | 0 | 0 | 0 | api.fda.gov |
| Mawi Dna Technologies | Pleasanton, CA, United States | Manufacturer, Repackager or relabeler | 1 | April 3, 2023 | 0 | 0 | 0 | api.fda.gov |
| Puritan Medical Products Company LLC | Guilford, ME, United States | Manufacturer | 1 | May 27, 2025 | 0 | 0 | 0 | api.fda.gov |
| Spectrum Solutions LLC | Draper, UT, United States | Manufacturer | 1 | February 17, 2023 | 0 | 0 | 0 | api.fda.gov |
| Strategic Lab Partners LLC | Memphis, TN, United States | Repackager or relabeler, Reprocessor | 1 | March 19, 2018 | 0 | 0 | 0 | api.fda.gov |
| Zhejiang Gene Science Co., Ltd | shaoxing Zhejiang, China | Manufacturer | 1 | April 8, 2024 | 0 | 0 | 0 | api.fda.gov |
| bioBoaVista | Valinhos Sao Paulo, Brazil | Manufacturer | 1 | June 17, 2024 | 0 | 0 | 0 | api.fda.gov |
| Cepheid | Sunnyvale, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cepheid AB | SOLNA Stockholm, Sweden | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Copan Diagnostics, Inc. | Murrieta, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cepheid | Lodi, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| EKF Life Sciences | South Bend, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jinan Babio Biotechnology Co.,ltd. | Jinan City Shandong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paidex Inc. | Pensacola, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rpi Biosolutions | Mundelein, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sio2 Medical Products, LLC | Auburn, AL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stanbio Laboratory | Boerne, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wuxi Nest Biotechnology Co., Ltd | Wuxi Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 27, 2025. 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.