Panels › Microbiology › Product code QBD · Class 2
Microbial Nucleic Acid Storage And Stabilization Device
Regulation 866.2950
0510(k)s in 12 months (17 all time)
0recalls in 12 months (7 all time)
0recalls that name a 510(k)
Top companies in QBD
| Company | 510(k)s | Recalls |
|---|---|---|
| Krishe Inc | 0 | 2 |
| Mercedes Medical, Inc. | 0 | 2 |
| Zymo Research | 2 | 0 |
| Aardvark Medical, Inc. | 1 | 0 |
| Alb Luz | 1 | 0 |
| BASE 10 GENETICS INC | 0 | 1 |
| Copan Italia Spa | 1 | 0 |
| DEWEI MEDICAL EQUIPMENT CO LTD | 0 | 1 |
| Fertipro NV | 1 | 0 |
| Hangzhou Bioer Technology Co., Ltd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 27, 2025 | K242820 | Puritan PurSafe Plus Collection and Transport System Puritan Medical Products, LLC | QBD |
| Oct 11, 2024 | K240797 | PPH Saliva Collection Kit Permantis Public Health | QBD |
| Jun 26, 2024 | K222771 | Sample Preservative Fluid Hangzhou Bioer Technology Co., Ltd., CN | QBD |
| Jun 17, 2024 | K233324 | Molecular Transport Media - MTM Alb Luz, BR | QBD |
| Jun 11, 2024 | K221547 | InActiv Blue Fertipro NV, BE | QBD |
| Apr 8, 2024 | K212878 | Sample preservation solution Zhejiang Gene Science Co., Ltd., CN | QBD |
| Sep 28, 2023 | K231013 | DNA/RNA Shield SafeCollect Saliva Collection kit Zymo Research | QBD |
| Jul 3, 2023 | K221664 | CLEARinse CTS Specimen Collection and Transport System Aardvark Medical, Inc. | QBD |
| Apr 3, 2023 | K221802 | iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL) Mawi Dna Technologies | QBD |
| Feb 17, 2023 | K223497 | Spectrum Saliva Collection Device Spectrum Solutions, LLC | QBD |
| Jan 19, 2023 | K220059 | Biosci Inactivated Transport Medium, Biosci ITM Shenzhen Dakewe Bio-Engineering Co., Ltd., CN | QBD |
| Aug 8, 2022 | K211675 | Dasky Disposable Sampling Tube (Model name: VSM02) Ningbo Dasky Life Science Co., Ltd., CN | QBD |
| Jul 28, 2022 | K212113 | MagXtract Collection Tube Magbio Genomics, Inc. | QBD |
| Sep 20, 2021 | K210440 | Disposable Sampler Inactivated Transport Media, Nest ITM Wuxi Nest Biotechnology Co., Ltd., CN | QBD |
| Dec 14, 2020 | K202641 | DNA/RNA Shield Collection Tube Zymo Research | QBD |
| Sep 17, 2020 | K201849 | eNAT molecular collection and preservation medium Copan Italia Spa, IT | QBD |
| Mar 19, 2018 | DEN170029 | PrimeStore MTM Longhorn Vaccines and Diagnostics, LLC | QBD |
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