Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System
PLO · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3970
Classification
FDA Product Code
PLO
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 866.3970
Review panel
MI
Medical specialty
Microbiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
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.