QBD — Microbial Nucleic Acid Storage And Stabilization Device Class II
FDA product code QBD covers "Microbial Nucleic Acid Storage And Stabilization Device", a Class II medical device regulated under 21 CFR 866.2950. Submissions are reviewed by the Microbiology panel. At least 17 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QBD
- Device Class
- Class II
- Regulation Number
- 866.2950
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K242820 | puritan medical products | Puritan PurSafe Plus Collection and Transport System | May 27, 2025 |
| K240797 | permantis public health | PPH Saliva Collection Kit | October 11, 2024 |
| K222771 | hangzhou bioer technology co | Sample Preservative Fluid | June 26, 2024 |
| K233324 | alb luz | Molecular Transport Media - MTM | June 17, 2024 |
| K221547 | fertipro | InActiv Blue | June 11, 2024 |
| K212878 | zhejiang gene science co | Sample preservation solution | April 8, 2024 |
| K231013 | zymo research | DNA/RNA Shield SafeCollect Saliva Collection kit | September 28, 2023 |
| K221664 | aardvark medical | CLEARinse CTS Specimen Collection and Transport System | July 3, 2023 |
| K221802 | mawi dna technologies | iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL) | April 3, 2023 |
| K223497 | spectrum solutions | Spectrum Saliva Collection Device | February 17, 2023 |
| K220059 | shenzhen dakewe bio-engineering co | Biosci Inactivated Transport Medium, Biosci ITM | January 19, 2023 |
| K211675 | ningbo dasky life science co | Dasky Disposable Sampling Tube (Model name: VSM02) | August 8, 2022 |
| K212113 | magbio genomics | MagXtract Collection Tube | July 28, 2022 |
| K210440 | wuxi nest biotechnology co | Disposable Sampler Inactivated Transport Media, Nest ITM | September 20, 2021 |
| K202641 | zymo research | DNA/RNA Shield Collection Tube | December 14, 2020 |
| K201849 | copan italia | eNAT molecular collection and preservation medium | September 17, 2020 |
| DEN170029 | longhorn vaccines and diagnostics | PrimeStore MTM | March 19, 2018 |