The following data is part of a premarket notification filed by Magbio Genomics, Inc. with the FDA for Magxtract Collection Tube.
| Device ID | K212113 |
| 510k Number | K212113 |
| Device Name: | MagXtract Collection Tube |
| Classification | Microbial Nucleic Acid Storage And Stabilization Device |
| Applicant | MagBio Genomics, Inc. 944 Clopper Rd Gaithersburg, MD 20878 |
| Contact | Mothomang Mlalazi-Oyinloye |
| Correspondent | Mukesh Kumar Brij Strategic Consultations, LLC 20271 Goldenrod Lane, Suite 2020 Germantown, MD 20876 |
| Product Code | QBD |
| CFR Regulation Number | 866.2950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-07 |
| Decision Date | 2022-07-28 |