Data / Medical devices / United States / Magbio Genomics Inc.
Magbio Genomics Inc.: FDA-registered device maker in Gaithersburg, MD, United States, 1 510(k) clearance
Magbio Genomics Inc. is registered with the FDA (registration 3013740892) in Gaithersburg, MD, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 28, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013740892
- Address
- 200 Professional Drive, Gaithersburg, MD, United States, 20879
- Owner or operator
- MagBio Genomics Inc. (10085547)
- Roles
- Specification developer
- First device listed
- August 17, 2022
- Registered through
- 2026
- Brand names listed
- MagCTL Collection Tube (Formerly MagXtract Collection Tube)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Microbial Nucleic Acid Storage And Stabilization Device | QBD | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 28, 2022 | K212113 | MagXtract Collection Tube | QBD | Substantially Equivalent | Magbio Genomics, Inc. | accessdata.fda.gov |
Compare with other makers
Updated July 28, 2022. 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.