FDA Review Panel · MI

FDA 510(k) Microbiology Devices

About Microbiology Devices

FDA 510(k) microbiology devices include diagnostic systems used to detect and identify bacteria, viruses, fungi and parasites. The FDA review panel code is MI.

Key device types:

  • Blood culture systems - automated incubation and detection platforms
  • Microbial identification - MALDI-TOF, biochemical and molecular ID systems
  • Antimicrobial susceptibility testing - MIC determination and breakpoint analysis
  • Rapid infectious disease tests - influenza, strep, RSV, COVID-19 antigen and molecular tests
  • Molecular diagnostics - PCR panels for respiratory, GI and STI pathogens

7038
Total
6976
Cleared
102d
Avg days
1976
Since
363 Microbiology devices
226–250 of 363
Cleared Apr 11, 2024
Azer Scientific Universal Transport Medium
K202531 · Azer Scientific, Inc.
JSM · Culture Media, Non-propagating Transport · 1318d
Cleared Apr 08, 2024
Sample preservation solution
K212878 · Zhejiang Gene Science Co., Ltd.
QBD · Microbial Nucleic Acid Storage And Stabilization Device · 942d
Cleared Apr 02, 2024
LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System
K211815 · Affinity Biosensors
SAN · Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples · 1026d
Cleared Mar 27, 2024
ARX Liquid Amies Collection & Transport System
K222613 · Arx Sciences, Inc.
LIO · Device, Specimen Collection · 575d
Cleared Mar 26, 2024
SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738)
K233611 · Maine Molecular Quality Controls, Inc.
PMN · Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays · 134d
Cleared Mar 26, 2024
BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel
K232954 · Biofire Diagnostics, LLC
QOF · Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents · 187d
Cleared Mar 22, 2024
Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5
K231806 · Oxoid Limited (Part of Thermo Fisher Scientific)
JTN · Susceptibility Test Discs, Antimicrobial · 276d
Cleared Mar 22, 2024
QuickVue COVID-19 Test
K231795 · Quidel Corporation
QYT · Over-the-counter Covid-19 Antigen Test · 276d
Cleared Mar 19, 2024
ARX Viral Transport Media Collection and Transport System
K231843 · Arx Sciences, Inc.
JSM · Culture Media, Non-propagating Transport · 271d
Cleared Mar 15, 2024
BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL)
K233986 · Becton, Dickinson and Company
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 88d
Cleared Mar 11, 2024
VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL)
K234000 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 84d
Cleared Mar 11, 2024
NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)
K231758 · Luminex Molecular Diagnostics, Inc.
QOF · Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents · 269d
Cleared Mar 01, 2024
LIAISON PLEX Respiratory Flex Assay
K233410 · Luminex Corporation
QOF · Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents · 147d
Cleared Feb 15, 2024
PBC Separator with Selux AST System
K223493 · Selux Diagnostics, Inc.
QZX · Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing · 451d
Cleared Feb 08, 2024
T2Bacteria® Panel
K233184 · T2biosystems, Inc.
QBX · Direct Blood Bacterial Nucleic Acid Detection System · 133d
Cleared Feb 08, 2024
eQUANT System
K231536 · Avails Medical, Inc.
QZX · Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing · 254d
Cleared Jan 26, 2024
Aptima Neisseria gonorrhoeae Assay
K231329 · Hologic, Inc.
LSL · Dna-reagents, Neisseria · 263d
Cleared Jan 23, 2024
Nano-Check™ COVID-19 Antigen Test
K231187 · Nano-Ditech Corporation
QVF · Simple Point-of-care Device To Directly Detect Sars-cov-2 Viral Targets From Clinical Specimens In Near-patient Settings · 272d
Cleared Dec 20, 2023
Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument
K232286 · Quidel Corporation
PGI · Herpes Virus (vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples · 141d
Cleared Dec 13, 2023
Sofia 2 SARS Antigen+ FIA
K233688 · Quidel Corporation
QVF · Simple Point-of-care Device To Directly Detect Sars-cov-2 Viral Targets From Clinical Specimens In Near-patient Settings · 26d
Cleared Dec 05, 2023
BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived Kit
K232434 · Bd
PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 116d
Cleared Dec 04, 2023
cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System
K223783 · Roche Molecular Systems, Inc.
QWR · Simple Point-of-care Device To Detect Sar-cov-2 Nucleic Acid Targets From Clinical Specimens In Near-patient Settings · 353d
Cleared Nov 16, 2023
Aptima® Chlamydia trachomatis Assay
K230451 · Hologic, Inc.
MKZ · Dna Probe, Nucleic Acid Amplification, Chlamydia · 268d
Cleared Nov 09, 2023
Flowflex COVID-19 Antigen Home Test
K230828 · ACON Laboratories, Inc.
QYT · Over-the-counter Covid-19 Antigen Test · 227d
Cleared Nov 06, 2023
Aptima Trichomonas vaginalis Assay
K231316 · Hologic, Inc.
OUY · Trichomonas Vaginalis Nucleic Acid Amplification Test System · 182d

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Search all Microbiology 510(k) devices
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All categories 363 JWY Manual Antimicrobial Susceptibility Test Systems 32 QOF Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents 29 LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation 27 PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System 15 JSM Culture Media, Non-propagating Transport 13 JTN Susceptibility Test Discs, Antimicrobial 13 QYT Over-the-counter Covid-19 Antigen Test 13 SCA Multi-analyte Respiratory Virus Antigen Detection Test 11 PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays 10 QQX Respiratory Specimen Nucleic Acid Sars-cov-2 Test 8 QVF Simple Point-of-care Device To Directly Detect Sars-cov-2 Viral Targets From Clinical Specimens In Near-patient Settings 8 QEP Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections 8 NGZ Susceptibility Test Plate, Antifungal 7 PQA Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System 6 LOL Hepatitis A Test (antibody And Igm Antibody) 6