Atlas FDA

QBD

17 FDA 510(k) clearances · Product code

286 daysmedian time to decision
746 days90th percentile
17clearances measured

FDA profile

Official device name
Microbial Nucleic Acid Storage And Stabilization Device
Device class
Class II (moderate risk)
Regulation
21 CFR 866.2950
Medical specialty
Microbiology
FDA 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.
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RecordFirmDate
Puritan PurSafe Plus Collection and Transport System (K242820)Puritan Medical Products, LLC2025-05-27
PPH Saliva Collection Kit (K240797)Permantis Public Health2024-10-11
Sample Preservative Fluid (K222771)Hangzhou Bioer Technology Co., Ltd.2024-06-26
Molecular Transport Media - MTM (K233324)Alb Luz2024-06-17
InActiv Blue (K221547)Fertipro NV2024-06-11
Sample preservation solution (K212878)Zhejiang Gene Science Co., Ltd.2024-04-08
DNA/RNA Shield SafeCollect Saliva Collection kit (K231013)Zymo Research2023-09-28
CLEARinse CTS Specimen Collection and Transport System (K221664)Aardvark Medical, Inc.2023-07-03
iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL) (K221802)Mawi Dna Technologies2023-04-03
Spectrum Saliva Collection Device (K223497)Spectrum Solutions, LLC2023-02-17
Biosci™ Inactivated Transport Medium, Biosci™ ITM (K220059)Shenzhen Dakewe Bio-Engineering Co., Ltd.2023-01-19
Dasky Disposable Sampling Tube (Model name: VSM02) (K211675)Ningbo Dasky Life Science Co., Ltd.2022-08-08
MagXtract Collection Tube (K212113)Magbio Genomics, Inc.2022-07-28
Disposable Sampler Inactivated Transport Media, Nest ITM (K210440)Wuxi Nest Biotechnology Co., Ltd.2021-09-20
DNA/RNA Shield Collection Tube (K202641)Zymo Research2020-12-14
eNAT molecular collection and preservation medium (K201849)Copan Italia Spa2020-09-17
PrimeStore MTM (DEN170029)Longhorn Vaccines and Diagnostics, LLC2018-03-19

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