Biosci Inactivated Transport Medium, Biosci ITM
FDA 510(k) K220059 · Shenzhen Dakewe Bio-Engineering Co., Ltd.
510(k) numberK220059
Submission
- Device name
- Biosci Inactivated Transport Medium, Biosci ITM
- Applicant
- Shenzhen Dakewe Bio-Engineering Co., Ltd.
Shenzhen, CN - Received
- January 10, 2022
- Decision date
- January 19, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QBD – Microbial Nucleic Acid Storage And Stabilization Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.2950
- Specialty
- Microbiology
Molecular transport media is a device intended for the stabilization and transportation of nucleic acids from unprocessed human samples suspected of containing infectious material.
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|---|---|---|---|
| K242820 | Puritan PurSafe Plus Collection and Transport SystemQBD · Traditional | Puritan Medical Products, LLC | 05/27/2025SE |
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| K231013 | DNA/RNA Shield SafeCollect Saliva Collection kitQBD · Traditional | Zymo Research | 09/28/2023SE |
| K221664 | CLEARinse CTS Specimen Collection and Transport SystemQBD · Traditional | Aardvark Medical, Inc. | 07/03/2023SE |
| K221802 | iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL)QBD · Traditional | Mawi Dna Technologies | 04/03/2023SE |
| K223497 | Spectrum Saliva Collection DeviceQBD · Traditional | Spectrum Solutions, LLC | 02/17/2023SE |
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Questions and answers
When was Biosci Inactivated Transport Medium, Biosci ITM cleared by the FDA?
Biosci Inactivated Transport Medium, Biosci ITM (K220059) received a 510(k) decision of Substantially Equivalent on January 19, 2023, 374 days after the submission was received.
What is the product code of K220059?
The FDA product code is QBD – Microbial Nucleic Acid Storage And Stabilization Device, a Class II (moderate risk) device regulated under 21 CFR 866.2950.