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QBQ

1 FDA 510(k) clearances · Product code

FDA profile

Official device name
System, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture
Device class
Class I (low risk)
Regulation
21 CFR 866.2560
Medical specialty
Microbiology
FDA definition
Qualitative, in vitro diagnostic system that monitors microbial growth directly from normally sterile body fluid sample incubated in a liquid culture medium
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RecordFirmDate
BacterioScan 216Dx System (K172412)Bacterioscan, Inc.2018-05-01

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