510(k) Report

Devices descending from K042970

24 later devices reach Copan Universal Transport Medium (Utm-RT) System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220908Ensol EnTM Specimen Collection and Transport SystemEnsol Biosciences, Inc.20240—
+1K240235OmniTrans Transport SystemShenzhen Dakewe Bio-Engineering Co., Ltd.20240—
+1K233534Viral Transport MediumHardy Diagnostics20240—
+1K202531Azer Scientific Universal Transport MediumAzer Scientific, Inc.20240—
+1K231027KaiBiLi Extended ViralTransHangzhou Genesis Biodetection & Biocontrol Co., Ltd.20230—
+1K212743MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/SCS30-A) SystemMedschenker, Inc.20231—
+1K230035BioSci™ Disposable Virus Sampling TubesShenzhen Dakewe Bio-Engineering Co., Ltd.20230—
+1K212856iClean Viral Transport System (VTM-RT kit)Huachenyang (Shenzhen) Technology Co., Ltd.20222—
+1K211256Disposable Sampler Viral Transport MediaWuxi Nest Biotechnology Co., Ltd.20220—
+1K171552Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample…Cepheid20171—
+1K151226Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress…Cepheid20154—
+1K142045Xpert Flu/RSV XC AssayCepheid20145—
+1K121039Copan Mswab Collection, Transport and Preservation SystemCopan Flock Technologies20121—
+1K113249Transport Culture Medium DevicePuritan Medical Products, LLC20124—
+2K233449Avantik VTMHanchang Medic Co., Ltd. (Han Chang Medic)20240—
+2K232454Viral Transport Media (VTM)Alb Luz20240—
+2K231843ARX Viral Transport Media Collection and Transport SystemArx Sciences, Inc.20240—
+2K211707BioTeke Sterile Disposable Virus Sampling KitBioteke Corporation (Wuxi) Co., Ltd.20220—
+2K201674Cultura Collection and Transport SystemMerit Medical Systems, Inc.20212—
+2K180218Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample…Cepheid20180—
+2K162456Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems…Cepheid20172—
+2K162331Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems…Cepheid20170—
+3K242576AllTest Viral Transport MediumHangzhou AllTest Biotech Co., Ltd.20250—
+3K232357Copan Universal Transport Medium (UTM-RT) SystemCopan Italia Spa20240—