Part 866 Subpart B—Diagnostic Devices

FDA submissions for Part 866 Subpart B—Diagnostic Devices in the Microbiology (MI) review panel, including product codes and regulations.

Section range: §§ 866.1620–866.1700

CFR Part: 866

Product Codes

Product CodeDevice NameRegulationClassDevices
JTNSusceptibility Test Discs, Antimicrobial866.16202328
LTXDiscs, Elution866.162022
JTTSusceptibility Test Powders, Antimicrobial866.1640224
JWYManual Antimicrobial Susceptibility Test Systems866.16402442
LIEReagent/Device, Inoculum Calibration866.164027
LOPSolution, Antimicrobial866.164023
LRGInstrument For Auto Reader & Interpretation Of Overnight Suscept. Systems866.1640245
LTTPanels, Test, Susceptibility, Antimicrobial866.1640252
LTWSusceptibility Test Cards, Antimicrobial866.1640217
MJASusceptibility Test Powders, Antimycobacterial866.164025
MYISystem, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies866.1640210
NGZSusceptibility Test Plate, Antifungal866.1640221
NIJSystem, Test, Genotypic Detection, Resistant Markers, Enterococcus Species866.164026
NQXSystem, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen866.1640224
PMYSystem, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony866.164023
POCSystem, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen866.164023
PTJPhenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates866.164023
LONSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation866.16452301
PRHPositive Blood Culture Identification And Ast Kit866.165022
QZXPositive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing866.165023
SANAutomated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples866.165026
QIVCulture-Based Short-Term Incubation Antimicrobial Resistance Assay866.165521
JSOCulture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar866.1700240
JTZCulture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth866.1700274
LKACulture Media, Antimicrobial Susceptibility Test866.170025
MJDCulture Media, Antimycobacteria, Susceptibility Test866.170023
MJECulture Media, Antifungal, Susceptibility Test866.170021
Innolitics

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