8 results
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33ms
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Sources: EU EUDAMED, US FDA
Qvella Corporation
Manufacturer
🇨🇦 Canada·1 Importer
FAST Instrument
FDA UDI
Qvella Corporation·B6011001000·The FAST™ System and FAST PBC Prep Cartridge ar...
FAST PBC Prep Cartridge
FDA UDI
Qvella Corporation·B6011002000·The FAST™ System and FAST PBC Prep Cartridge ar...
Qvella Corporation Belgium
Importer
🇧🇪 Belgium
The FAST System and the FAST PBC Prep Cartridge together are a closed, rapid and automated sample preparation system for isolating bacterial cells directly from a positive blood culture (PBC). The cartridge and instrument isolate and concentrate bacterial cells directly from PBC by removing blood, cellular and culture media matrix components from the sample, thereby reducing the sample volume considerably while maintaining bacterial cell viability. The resulting material is a purified microbial suspension or Liquid Colony for use in downstream in vitro diagnostics.
FDA Recall
Open, Classified
·Qvella Corporation·Product code JJH·November 2, 2022
The FAST System and the FAST PBC Prep Cartridge together are a closed, rapid and automated sample preparation system for isolating bacterial cells directly from a positive blood culture (PBC). The cartridge and instrument isolate and concentrate bacterial cells directly from PBC by removing blood, cellular and culture media matrix components from the sample, thereby reducing the sample volume considerably while maintaining bacterial cell viability. The resulting material is a purified microbial suspension or Liquid Colony for use in downstream in vitro diagnostics.
FDA Enforcement
Class II
·Ongoing·Qvella Corporation·December 14, 2022
WMDE B.V.
Authorized representative
🇳🇱 Netherlands·14 Manufacturers·47 Devices
Triolab AS
Importer
🇩🇰 Denmark·11 Manufacturers