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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

CountryMakers
United States15
China4
Italy1
Belgium1
Brazil1
Sweden1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Blue Life Solutions, LLC.Las Vegas, NV, United StatesManufacturer, Repackager or relabeler2September 28, 2023000api.fda.gov
Copan ItaliaBRESCIA Lombardy, ItalyContract manufacturer, Manufacturer1September 17, 2020000api.fda.gov
Fertipro N.V.BEERNEM West-Vlaanderen, BelgiumManufacturer1June 11, 2024000api.fda.gov
Hangzhou Bioer Technology Co., LtdHangzhou Zhejiang, ChinaManufacturer1June 26, 2024000api.fda.gov
Longhorn Vaccines and Diagnostics LLCBethesda, MD, United StatesComplaint file establishment, Specification developer1March 19, 2018010api.fda.gov
Magbio Genomics Inc.Gaithersburg, MD, United StatesSpecification developer1July 28, 2022000api.fda.gov
Mawi Dna TechnologiesPleasanton, CA, United StatesManufacturer, Repackager or relabeler1April 3, 2023000api.fda.gov
Puritan Medical Products Company LLCGuilford, ME, United StatesManufacturer1May 27, 2025000api.fda.gov
Spectrum Solutions LLCDraper, UT, United StatesManufacturer1February 17, 2023000api.fda.gov
Strategic Lab Partners LLCMemphis, TN, United StatesRepackager or relabeler, Reprocessor1March 19, 2018000api.fda.gov
Zhejiang Gene Science Co., Ltdshaoxing Zhejiang, ChinaManufacturer1April 8, 2024000api.fda.gov
bioBoaVistaValinhos Sao Paulo, BrazilManufacturer1June 17, 2024000api.fda.gov
CepheidSunnyvale, CA, United StatesManufacturer0000api.fda.gov
Cepheid ABSOLNA Stockholm, SwedenContract manufacturer0000api.fda.gov
Copan Diagnostics, Inc.Murrieta, CA, United StatesContract manufacturer0000api.fda.gov
CepheidLodi, CA, United StatesManufacturer0000api.fda.gov
EKF Life SciencesSouth Bend, IN, United StatesContract manufacturer0000api.fda.gov
Jinan Babio Biotechnology Co.,ltd.Jinan City Shandong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Paidex Inc.Pensacola, FL, United StatesContract manufacturer0000api.fda.gov
Rpi BiosolutionsMundelein, IL, United StatesContract manufacturer0000api.fda.gov
Sio2 Medical Products, LLCAuburn, AL, United StatesContract manufacturer0000api.fda.gov
Stanbio LaboratoryBoerne, TX, United StatesContract manufacturer0000api.fda.gov
Wuxi Nest Biotechnology Co., LtdWuxi Jiangsu, ChinaContract manufacturer0000api.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.