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Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing

FDA product code QZX · 3 cleared devices

Class 2 Microbiology
Regulation
21 CFR 866.1650
Review panel
MI
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2024-02-08 – 2025-03-28

Processing device that includes associated reagents, when applicable, that is intended to recover microbes from positive blood cultures for inoculum preparation. The prepared inoculum is intended for subsequent use in antimicrobial susceptibility testing.

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