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
Not Cleared
Jul 15, 2024
Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390)
SBT
Device To Detect Microbial Colonization Directly From Clinical Specimens.
200d
Cleared
Jul 10, 2024
Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit
QQX
Respiratory Specimen Nucleic Acid Sars-cov-2 Test
264d
Not Cleared
Jun 27, 2024
Xpert HCV
SBP
Simple Point-of-care Nucleic Acid-based Hepatitis C Virus Ribonucleic Acid Test
72d
Cleared
Jun 26, 2024
Sample Preservative Fluid
QBD
Microbial Nucleic Acid Storage And Stabilization Device
651d
Cleared
Jun 21, 2024
CorDx Tyfast COVID-19 Ag Rapid Test
QYT
Over-the-counter Covid-19 Antigen Test
95d
Cleared
Jun 20, 2024
VITEK REVEAL GN AST Assay and VITEK REVEAL AST System
SAN
Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples
468d
Cleared
Jun 17, 2024
Molecular Transport Media - MTM
QBD
Microbial Nucleic Acid Storage And Stabilization Device
262d
Cleared
Jun 12, 2024
VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)
NGZ
Susceptibility Test Plate, Antifungal
265d
Cleared
Jun 11, 2024
InActiv Blue
QBD
Microbial Nucleic Acid Storage And Stabilization Device
746d
Cleared
Jun 07, 2024
VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)
NGZ
Susceptibility Test Plate, Antifungal
260d
Cleared
Jun 04, 2024
LIAISON PLEX Yeast Blood Culture Assay
PEO
Fungal Organisms, Nucleic Acid-based Assay
90d
Cleared
May 31, 2024
iHealth COVID-19 Antigen Rapid Test
QYT
Over-the-counter Covid-19 Antigen Test
179d
Cleared
May 31, 2024
QIAstat-Dx Gastrointestinal Panel 2
PCH
Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System
872d
Cleared
May 30, 2024
SPOTFIRE RSP Pos & Neg Controls
PMN
Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays
23d
Cleared
May 30, 2024
BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini
QOF
Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents
30d
Cleared
May 29, 2024
EasyScreen Gastrointestinal Parasite Detection Kit
PCH
Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System
271d
Cleared
May 21, 2024
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4)
OZE
Influenza A And Influenza B Multiplex Nucleic Acid Assay
29d
Cleared
May 16, 2024
The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Imipenem in the dilution range of 0.015 - 4 ug/ml.
JWY
Manual Antimicrobial Susceptibility Test Systems
91d
Cleared
May 10, 2024
QIAstat-Dx® Respiratory Panel Plus
QOF
Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents
227d
Cleared
May 03, 2024
Alinity m HSV 1 & 2 / VZV
PGI
Herpes Virus (vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
217d
Cleared
May 03, 2024
Viral Transport Media (VTM)
JSM
Culture Media, Non-propagating Transport
263d
Cleared
Apr 26, 2024
ASTar BC G- Kit and ASTar Instrument
SAN
Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples
686d
Cleared
Apr 25, 2024
Copan Universal Transport Medium (UTM-RT) System
JSM
Culture Media, Non-propagating Transport
262d
Cleared
Apr 19, 2024
Flowflex® Plus COVID-19 Home Test
QYT
Over-the-counter Covid-19 Antigen Test
200d
Cleared
Apr 19, 2024
Healgen Rapid COVID-19 Antigen Test
QVF
Simple Point-of-care Device To Directly Detect Sars-cov-2 Viral Targets From Clinical Specimens In Near-patient Settings
255d
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