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Microbial Nucleic Acid Storage And Stabilization Device

FDA product code QBD · Class 2 · Microbiology

40
Registered devices
0
Adverse events
7
Recalls
17
510(k) clearances

Devices with this code

Dakewe — Shenzhen Dakewe Bio-engineering Co., LtdBioSci™ — Shenzhen Dakewe Bio-engineering Co., LtdDakewe — Shenzhen Dakewe Bio-engineering Co., LtdPrimeStore MTM — Longhorn Vaccines And Diagnostics, LLCDakewe — Shenzhen Dakewe Bio-engineering Co., LtdXpert Swab Specimen Collection Kit — CEPHEIDeNAT® — COPAN ITALIA SPADakewe — Shenzhen Dakewe Bio-engineering Co., LtdDakewe — Shenzhen Dakewe Bio-engineering Co., LtdDTPM — Shenzhen Dakewe Bio-engineering Co., LtdeNAT® — COPAN ITALIA SPABIOER Sample Preservative Fluid — Hangzhou Bioer Technology Co., Ltd.Dakewe — Shenzhen Dakewe Bio-engineering Co., LtdDakewe — Shenzhen Dakewe Bio-engineering Co., LtdBioSci™ — Shenzhen Dakewe Bio-engineering Co., LtdPrimeStore MTM — Longhorn Vaccines And Diagnostics, LLCMagbio Genomics, Inc. — Magbio Genomics, Inc.BioSci™ — Shenzhen Dakewe Bio-engineering Co., LtdMagbio Genomics, Inc. — Magbio Genomics, Inc.DTPM — Shenzhen Dakewe Bio-engineering Co., LtdMolecular Transport Media (MTM) 3ml — A. L. B. LUZDakewe — Shenzhen Dakewe Bio-engineering Co., LtdPrimeStore MTM — Longhorn Vaccines And Diagnostics, LLCDakewe — Shenzhen Dakewe Bio-engineering Co., Ltd

Recent recalls

DateFirmReason
2022-08-09DEWEI MEDICAL EQUIPMENT CO LTDProducts were distributed in the United States without FDA authorization or clearance.
2022-01-10BASE 10 GENETICS INCThe product does not have 510(k) clearance.
2021-06-10Mercedes Medical, Inc.No 510(k) clearance
2021-06-10Mercedes Medical, Inc.No 510(k) clearance
2021-03-11Krishe IncVerification and validation of the virus transport medium tubes was not provided to FDA prior to sale and marketing
2021-03-11Krishe IncVerification and validation of the virus transport medium tubes was not provided to FDA prior to sale and marketing
2020-06-03LONGHORN VACCINES AND DIAGNOSTICThe tubes may have been delivered to some users without labels. Users may not be able to identify the tubes without these labels. If samples stored or transport

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.