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Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System

FDA product code PLO · 3 cleared devices

Class 2 Microbiology
Regulation
21 CFR 866.3970
Review panel
MI
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2016-03-17 – 2024-10-29

A meningitis/encephalitis pathogen multiplex nucleic acid detection system is a qualitative in vitro diagnostic test for the direct detection and identification of microbial-associated nucleic acids in cerebrospinal fluid. The test is indicated for individuals with signs and symptoms of meningitis or encephalitis and aids in diagnosis of agents of meningitis or encephalitis when used in conjunction with clinical and other laboratory findings.

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