510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PLOClass II

Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System

21 CFR 866.3970 / Microbiology
FDA source (opens on fda.gov)

PLO is the FDA product code for Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System, a class II device type, regulated under 21 CFR 866.3970. FDA's definition for this code reads: "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...". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
PLO
Device name
Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System
FDA 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.
Regulation
21 CFR 866.3970
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
2

Clearances, product code PLO

By decision year
4 clearances under product code PLO with a decision year between 2015 and 2024, 2015 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PLO by decision year
YearClearances
20151
20161
20191
20241

Applicants with the most clearances

Product code PLO
Applicants holding the most 510(k) clearances under product code PLO
ApplicantClearances
BioFire Diagnostics, LLC2
DiaSorin Molecular LLC1
Qiagen1

Companies listing this code with FDA

Companies whose registered establishments list this code