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System, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture

FDA product code QBQ · 1 cleared devices

Class 1 Microbiology
Regulation
21 CFR 866.2560
Review panel
MI
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2018-05-01 – 2018-05-01

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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