Product code QBD
- Device name
- Microbial Nucleic Acid Storage And Stabilization Device
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.2950
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- 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.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242820 | Puritan PurSafe Plus Collection and Transport System | Puritan Medical Products, LLC | 2025-05-27 |
| K240797 | PPH Saliva Collection Kit | Permantis Public Health | 2024-10-11 |
| K222771 | Sample Preservative Fluid | Hangzhou Bioer Technology Co., Ltd. | 2024-06-26 |
| K233324 | Molecular Transport Media - MTM | Alb Luz | 2024-06-17 |
| K221547 | InActiv Blue | Fertipro NV | 2024-06-11 |
| K212878 | Sample preservation solution | Zhejiang Gene Science Co., Ltd. | 2024-04-08 |
| K231013 | DNA/RNA Shield SafeCollect Saliva Collection kit | Zymo Research | 2023-09-28 |
| K221664 | CLEARinse CTS Specimen Collection and Transport System | Aardvark Medical, Inc. | 2023-07-03 |
| K221802 | iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL) | Mawi Dna Technologies | 2023-04-03 |
| K223497 | Spectrum Saliva Collection Device | Spectrum Solutions, LLC | 2023-02-17 |
| K220059 | Biosci™ Inactivated Transport Medium, Biosci™ ITM | Shenzhen Dakewe Bio-Engineering Co., Ltd. | 2023-01-19 |
| K211675 | Dasky Disposable Sampling Tube (Model name: VSM02) | Ningbo Dasky Life Science Co., Ltd. | 2022-08-08 |
| K212113 | MagXtract Collection Tube | Magbio Genomics, Inc. | 2022-07-28 |
| K210440 | Disposable Sampler Inactivated Transport Media, Nest ITM | Wuxi Nest Biotechnology Co., Ltd. | 2021-09-20 |
| K202641 | DNA/RNA Shield Collection Tube | Zymo Research | 2020-12-14 |
| K201849 | eNAT molecular collection and preservation medium | Copan Italia Spa | 2020-09-17 |
| DEN170029 | PrimeStore MTM | Longhorn Vaccines and Diagnostics, LLC | 2018-03-19 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06974679160768 | ZHEJIANG GENE SCIENCE | ZHEJIANG GENE SCIENCE CO., LTD. | 2026-05-11 |
| 06974679160201 | ZHEJIANG GENE SCIENCE | ZHEJIANG GENE SCIENCE CO., LTD. | 2026-05-11 |
| 10850045030008 | Magbio Genomics, Inc. | Magbio Genomics, Inc. | 2026-03-27 |
| 00850049735490 | Magbio Genomics, Inc. | Magbio Genomics, Inc. | 2026-03-27 |
| 00850045030018 | Magbio Genomics, Inc. | Magbio Genomics, Inc. | 2026-03-27 |
| B9030201 | PrimeStore MTM | Longhorn Vaccines And Diagnostics, LLC | 2025-11-03 |
| B9030315 | PrimeStore MTM | Longhorn Vaccines And Diagnostics, LLC | 2025-11-03 |
| 07898996204655 | Molecular Transport Media (MTM) 3ml | A. L. B. LUZ | 2024-08-29 |
| 07898996204648 | Molecular Transport Media (MTM) 2ml | A. L. B. LUZ | 2024-08-29 |
| 05411967003471 | InActiv Blue | Fertipro NV | 2024-08-14 |
| 05411967003464 | InActiv Blue | Fertipro NV | 2024-08-14 |
| 06973843228914 | Sample Preservative Fluid | Hangzhou Bioer Technology Co., Ltd. | 2024-07-15 |
| 16973471968784 | DTPM | Shenzhen Dakewe Bio-engineering Co., Ltd | 2024-06-07 |
| 26973471968781 | DTPM | Shenzhen Dakewe Bio-engineering Co., Ltd | 2024-06-07 |
| 06973471968763 | DTPM | Shenzhen Dakewe Bio-engineering Co., Ltd | 2024-05-20 |
| B90305154 | PrimeStore MTM | Longhorn Vaccines And Diagnostics, LLC | 2024-03-20 |
| B9030515500 | PrimeStore MTM | Longhorn Vaccines And Diagnostics, LLC | 2024-03-20 |
| B90305153 | PrimeStore MTM | Longhorn Vaccines And Diagnostics, LLC | 2024-02-27 |
| B90305151000 | PrimeStore MTM | Longhorn Vaccines And Diagnostics, LLC | 2024-02-27 |
| B90312033 | PrimeStore MTM | Longhorn Vaccines And Diagnostics, LLC | 2024-02-09 |
| B90312023 | PrimeStore MTM | Longhorn Vaccines And Diagnostics, LLC | 2024-02-09 |
| B90312032 | PrimeStore MTM | Longhorn Vaccines And Diagnostics, LLC | 2024-02-07 |
| B90312022 | PrimeStore MTM | Longhorn Vaccines And Diagnostics, LLC | 2024-02-07 |
| B90305151 | PrimeStore MTM | Longhorn Vaccines And Diagnostics, LLC | 2024-02-07 |
| B903051550 | PrimeStore MTM | Longhorn Vaccines And Diagnostics, LLC | 2024-02-07 |
| 06973843228143 | BIOER Sample Preservative Fluid | Hangzhou Bioer Technology Co., Ltd. | 2023-01-11 |
| 07332940008345 | Xpert® | CEPHEID | 2022-04-12 |
| 38053326009700 | eNAT® | COPAN ITALIA SPA | 2021-02-16 |
| 38053326009694 | eNAT® | COPAN ITALIA SPA | 2021-02-16 |
| 38053326009687 | eNAT® | COPAN ITALIA SPA | 2021-02-16 |