QBD
- Product code
- QBD
- Device name
- Microbial Nucleic Acid Storage And Stabilization Device
- Device class
- Class 2
- 21 CFR
- 21 CFR 866.2950
- Medical specialty
- Microbiology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 7
- Summaries archived here
- 7 (direct download)
- 510(k) clearances (all years, FDA)
- 17 (all years; only the last 3 years are listed here)
FDA classification 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.
510(k) clearances, last 3 years (7)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K242820 | 2025-05-27 | Puritan Medical Products, LLC | Puritan PurSafe Plus Collection and Transport System | |
| K240797 | 2024-10-11 | Permantis Public Health | PPH Saliva Collection Kit | |
| K222771 | 2024-06-26 | Hangzhou Bioer Technology Co., Ltd. | Sample Preservative Fluid | |
| K233324 | 2024-06-17 | Alb Luz | Molecular Transport Media - MTM | |
| K221547 | 2024-06-11 | Fertipro NV | InActiv Blue | |
| K212878 | 2024-04-08 | Zhejiang Gene Science Co., Ltd. | Sample preservation solution | |
| K231013 | 2023-09-28 | Zymo Research | DNA/RNA Shield SafeCollect Saliva Collection kit |
Official FDA classification page: QBD
Classification and pathway per current FDA publications. Data from openFDA (CC0).