Transport Medium, Notified Per The Vtm Guidance
Microbiology · 21 CFR 866.2390
Notified transport media and collection devices intended for specimen collection and transport for use in detection of respiratory viruses including coronavirus per the guidance (Notified transport media and collection devices intended for specimen collection and transport for use in detection of respiratory viruses including coronavirus).
Recent MDR events
3 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
4 recall events for this product code
- Edge Biologicals IncOpen, ClassifiedApr 23, 2025
Edge Biologicals
Due to product outer packaging incorrectly labeled.
Z-1658-2025 · View FDA record ↗ - Haimen Shengbang Laboratory Equipment Co. Ltd.Open, ClassifiedUnknown
HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59 Activated Type
Distributed VTM outside of VTM Guidance and without clearance.
Z-1398-2022 · View FDA record ↗ - Haimen Shengbang Laboratory Equipment Co. Ltd.Open, ClassifiedUnknown
HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59-1
Distributed VTM outside of VTM Guidance and without clearance.
Z-1399-2022 · View FDA record ↗ - Haimen Shengbang Laboratory Equipment Co. Ltd.Open, ClassifiedUnknown
HXBL/WETEX/Genesis Biomedical Viral Transport Container, Custom Made
Distributed VTM outside of VTM Guidance and without clearance.
Z-1400-2022 · View FDA record ↗
Registered firms
15 firms currently registered for this product code
The Ruhof Corporation
Mineola, NY, US
Liofilchem, Inc.
Waltham, MA, US
Citotest Scientific Co.,ltd.
Nanjing Jiangsu, CN
Citotest Labware Manufacturing Co., Ltd.
Haimen Jiangsu, CN
Liofilchem S.r.l.
Roseto degli Abruzzi Teramo, IT
Wuxi Nest Biotechnology Co., Ltd
Wuxi Jiangsu, CN
Greiner Bio-one Gmbh
KREMSMUENSTER Oberosterreich, AT
Xcell Therapeutics Inc.
Yongin-si Gyeonggi, KR
Changsha Renji Medical Equipment Co., Ltd.
Changsha Hunan, CN
Azer Scientific, Inc.
Morgantown, PA, US
Bioboavista
Valinhos Sao Paulo, BR
Jiangsu Rongye Technology Co.,ltd
Yangzhou Jiangsu, CN
Jinan Babio Biotechnology Co.,ltd.
Jinan City Shandong, CN
Himedia Laboratories Private Limited
NASHIK Maharashtra, IN
Sts Corporation
Duluth, GA, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.