| FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
| K221664 |
Aardvark Medical, Inc. |
CLEARinse CTS Specimen Collection and Transport System |
07/03/2023 |
| K233324 |
ALB Luz |
Molecular Transport Media - MTM |
06/17/2024 |
| K201849 |
Copan Italia S.p.A. |
eNAT molecular collection and preservation medium |
09/17/2020 |
| K221547 |
FertiPro NV |
InActiv Blue |
06/11/2024 |
| K222771 |
Hangzhou Bioer Technology Co., LTD |
Sample Preservative Fluid |
06/26/2024 |
| DEN170029 |
Longhorn Vaccines and Diagnostics LLC |
PrimeStore MTM |
03/19/2018 |
| K212113 |
MagBio Genomics, Inc. |
MagXtract Collection Tube |
07/28/2022 |
| K221802 |
Mawi DNA Technologies |
iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL) |
04/03/2023 |
| K211675 |
Ningbo Dasky Life Science Co., Ltd. |
Dasky Disposable Sampling Tube (Model name: VSM02) |
08/08/2022 |
| K240797 |
Permantis Public Health |
PPH Saliva Collection Kit |
10/11/2024 |
| K242820 |
Puritan Medical Products LLC |
Puritan PurSafe Plus Collection and Transport System |
05/27/2025 |
| K220059 |
Shenzhen Dakewe Bio-engineering Co., Ltd. |
BiosciÖ Inactivated Transport Medium, BiosciÖ ITM |
01/19/2023 |
| K223497 |
Spectrum Solutions, LLC |
Spectrum Saliva Collection Device |
02/17/2023 |
| K210440 |
Wuxi Nest Biotechnology Co., Ltd. |
Disposable Sampler Inactivated Transport Media, Nest ITM |
09/20/2021 |
| K212878 |
Zhejiang GENE SCIENCE Co., Ltd. |
Sample preservation solution |
04/08/2024 |
| K202641 |
Zymo Research |
DNA/RNA Shield Collection Tube |
12/14/2020 |
| K231013 |
Zymo Research |
DNA/RNA Shield SafeCollect Saliva Collection kit |
09/28/2023 |