510(k) Report

Devices descending from DEN170029

16 later devices reach PrimeStore MTM through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222771Sample Preservative FluidHangzhou Bioer Technology Co., Ltd.20240—
+1K221664CLEARinse CTS Specimen Collection and Transport SystemAardvark Medical, Inc.20230—
+1K212113MagXtract Collection TubeMagbio Genomics, Inc.20221—
+1K210440Disposable Sampler Inactivated Transport Media, Nest ITMWuxi Nest Biotechnology Co., Ltd.20210—
+1K202641DNA/RNA Shield Collection TubeZymo Research20207—
+1K201849eNAT molecular collection and preservation mediumCopan Italia Spa20202—
+2K242820Puritan PurSafe Plus Collection and Transport SystemPuritan Medical Products, LLC20250—
+2K233324Molecular Transport Media - MTMAlb Luz20240—
+2K221547InActiv BlueFertipro NV20240—
+2K212878Sample preservation solutionZhejiang Gene Science Co., Ltd.20240—
+2K231013DNA/RNA Shield SafeCollect Saliva Collection kitZymo Research20230—
+2K221802iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL)Mawi Dna Technologies20230—
+2K223497Spectrum Saliva Collection DeviceSpectrum Solutions, LLC20231—
+2K220059Biosci™ Inactivated Transport Medium, Biosci™ ITMShenzhen Dakewe Bio-Engineering Co., Ltd.20230—
+2K211675Dasky Disposable Sampling Tube (Model name: VSM02)Ningbo Dasky Life Science Co., Ltd.20220—
+3K240797PPH Saliva Collection KitPermantis Public Health20240—