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
Cleared
Jan 27, 2026
Access anti-HAV IgM
LOL
Hepatitis A Test (antibody And Igm Antibody)
214d
Cleared
Jan 22, 2026
PhenoMATRIX
PPU
Microbial Colony Image Assessment System
251d
Cleared
Jan 16, 2026
Xpert GI Panel
PCH
Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System
226d
Cleared
Jan 15, 2026
Nano-Check Influenza A+B Test
PSZ
Devices Detecting Influenza A, B, And C Virus Antigens
177d
Cleared
Dec 30, 2025
Multichem ID-G (09339892190)
QCH
Assayed Quality Control Material For Clinical Microbiology Assays
496d
Cleared
Dec 23, 2025
LIAISON NES FLU A/B, RSV & COVID-19
QOF
Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents
179d
Not Cleared
Dec 23, 2025
LIAISON® XL MUREX Anti-HDV (318260)
SGW
Device To Detect Antibodies To Hepatitis D Virus
146d
Cleared
Dec 17, 2025
Elecsys Anti-SARS-CoV-2
QVP
Sars-cov-2 Serology Test
16d
Cleared
Dec 12, 2025
iHealth Flu A&B/COVID-19 Rapid Test
SCA
Multi-analyte Respiratory Virus Antigen Detection Test
246d
Cleared
Dec 12, 2025
iHealth Flu A&B/COVID-19/RSV Rapid Test
SCA
Multi-analyte Respiratory Virus Antigen Detection Test
247d
Cleared
Dec 05, 2025
Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10
JTN
Susceptibility Test Discs, Antimicrobial
219d
Cleared
Nov 26, 2025
Flowflex® Plus Strep A Rapid Test Cassette
GTY
Antigens, All Groups, Streptococcus Spp.
177d
Cleared
Nov 26, 2025
Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device
JSM
Culture Media, Non-propagating Transport
426d
Cleared
Nov 20, 2025
HardyDisk AST Cefiderocol 30µg (FDC30)
JTN
Susceptibility Test Discs, Antimicrobial
57d
Cleared
Nov 20, 2025
cobas liat Bordetella panel nucleic acid test
OZZ
Bordetella Pertussis Dna Assay System
350d
Cleared
Nov 19, 2025
IntelliSep Test
QUT
Deformability Cytometry For Sepsis Risk Assessment
237d
Cleared
Nov 17, 2025
Access Rubella IgG
LFX
Enzyme Linked Immunoabsorbent Assay, Rubella
263d
Cleared
Nov 14, 2025
Lyme-ID IgG Test
LSR
Reagent, Borrelia Serological Reagent
86d
Cleared
Nov 14, 2025
Status™ COVID-19/Flu A&B
SCA
Multi-analyte Respiratory Virus Antigen Detection Test
179d
Cleared
Nov 03, 2025
cobas HCV
MZP
Assay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus
88d
Cleared
Nov 03, 2025
cobas CMV
PAB
Cytomegalovirus (cmv) Dna Quantitative Assay
88d
Cleared
Oct 31, 2025
BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR System
PCI
Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-based Assay System
266d
Cleared
Oct 30, 2025
Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450)
QOF
Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents
91d
Cleared
Oct 27, 2025
LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system
SAN
Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples
131d
Cleared
Oct 22, 2025
QIAstat-Dx Gastrointestinal Panel 2
PCH
Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System
89d
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