QBDClass II
Microbial Nucleic Acid Storage And Stabilization Device
21 CFR 866.2950 / Microbiology
QBD is the FDA product code for Microbial Nucleic Acid Storage And Stabilization Device, a class II device type, regulated under 21 CFR 866.2950. FDA's definition for this code reads: "Molecular transport media is a device intended for the stabilization and transportation of nucleic acids from unprocessed human samples suspected of containing infectious material". As of , FDA records hold 17 510(k) clearances under this code, the most recent dated , and 7 recalls.
Classification record
- Product code
- QBD
- Device name
- Microbial Nucleic Acid Storage And Stabilization Device
- FDA definition
- Molecular transport media is a device intended for the stabilization and transportation of nucleic acids from unprocessed human samples suspected of containing infectious material.
- Regulation
- 21 CFR 866.2950
- Device class
- Class II
- Review panel
- Microbiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 17
- Ingested recalls
- 7
Clearances, product code QBD
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2018 | 1 |
| 2020 | 2 |
| 2021 | 1 |
| 2022 | 2 |
| 2023 | 5 |
| 2024 | 5 |
| 2025 | 1 |
Applicants with the most clearances
Product code QBD| Applicant | Clearances |
|---|---|
| Zymo Research | 2 |
| Aardvark Medical | 1 |
| Alb Luz | 1 |
| Copan Italia | 1 |
| Fertipro N.V. | 1 |
| Hangzhou Bioer Technology Co., Ltd | 1 |
| Longhorn Vaccines and Diagnostics LLC | 1 |
| Magbio Genomics Inc. | 1 |
| Mawi DNA Technologies | 1 |
| Ningbo Dasky Life Science Co., Ltd. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.