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Positive Blood Culture Identification And Ast Kit

FDA product code PRH · 1 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
2020-09-15 – 2020-09-15

Fluorescence in situ hybridization (FISH) identification and quantitative, antimicrobial susceptibility testing (AST) kit intended for simultaneous detection and identification of multiple microbial targets.

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