510(k) K212113
- Device
- MagXtract Collection Tube
- Applicant
- MagBio Genomics, Inc.
- 510(k) number
- K212113
- Product code
- QBD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-07-28
- Date received
- 2021-07-07
- Regulation
- 866.2950
- Classification name
- Microbial Nucleic Acid Storage And Stabilization Device
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Mothomang Mlalazi-Oyinloye
- Address
- 944 Clopper Rd. Gaithersburg MD US 20878 20878
FDA Registration Numbers#
- 3016635427
- 3009613136
- 3016764932
- 3003272500
- 3027266036
- 3010407203
- 1616487
- 3017101757
- 2436875
- 3004530258
- 3016838963
- 3009302820
- 3002444944
- 3025663244
- 3017830316
- 3013740892
- 3012758946
- 3031001098
- 3013373509
- 3013046485
- 3011818318
- 3017170972
- 3016741564
- 3017014794
- 1216735
Source Documents#
Other 510(k) Records For Product Code QBD #
| 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 |
| 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 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases