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Babio
Jinan Babio Biotechnology Co., Ltd. · Model VTM · UDI-DI 06975025173852
0
510(k) clearances
3
Adverse events
4
Recalls
15
Facilities
Description
Babio® Virus Transport Kit (Non-inactivated) is intended for the collection and transport of clinical specimens containing viruses from the collection site to the testing laboratory. It measures viral particles in the samples using molecular or antigen assays. Not intended for internal use.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-10-02 | Edge Biologicals Inc | Due to product outer packaging incorrectly labeled. |
| 2022-07-12 | Haimen Shengbang Laboratory Equipment Co. Ltd. | Distributed VTM outside of VTM Guidance and without clearance. |
| 2022-07-12 | Haimen Shengbang Laboratory Equipment Co. Ltd. | Distributed VTM outside of VTM Guidance and without clearance. |
| 2022-07-12 | Haimen Shengbang Laboratory Equipment Co. Ltd. | Distributed VTM outside of VTM Guidance and without clearance. |
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