QBD — Microbial Nucleic Acid Storage And Stabilization Device Class II
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 |