FDA 510(k) Microbiology Devices
FDA 510(k) Microbiology Devices - Regulatory Overview
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
7048
Total
6986
Cleared
159d
Avg (2y)
1976
Since
1404 Microbiology devices
Cleared
Jan 04, 2023
Elecsys Anti-HCV II (08837031190)
MZO
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
208d
Cleared
Dec 21, 2022
BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30)
JTN
Susceptibility Test Discs, Antimicrobial
181d
Cleared
Dec 20, 2022
IntelliSep test
QUT
Deformability Cytometry For Sepsis Risk Assessment
260d
Cleared
Dec 19, 2022
BreathID Hp System
MSQ
Test, Urea (breath Or Blood)
172d
Cleared
Dec 16, 2022
Copan FecalSwab Collection, Transport and Preservation System
JSM
Culture Media, Non-propagating Transport
344d
Cleared
Dec 09, 2022
LIAISON Anti-HAV
LOL
Hepatitis A Test (antibody And Igm Antibody)
30d
Cleared
Nov 17, 2022
Disposable Urine Collection Tube
JSM
Culture Media, Non-propagating Transport
248d
Cleared
Nov 10, 2022
BreathID® Smart System
MSQ
Test, Urea (breath Or Blood)
29d
Cleared
Nov 05, 2022
Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack
QDZ
Qualitative Cytomegalovirus Nucleic Acid-based Detection Device For Congenital Cytomegalovirus Infection
775d
Cleared
Nov 04, 2022
cobas HCV
MZP
Assay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus
213d
Cleared
Oct 27, 2022
Architect CMV IgG
LFZ
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
209d
Cleared
Oct 27, 2022
FilmArray Pneumonia Panel plus
QDS
Mers-cov And Common Respiratory Pathogens Semi-quantitative And Quantitative Multiplex Nucleic Acid Detection System
59d
Cleared
Oct 22, 2022
cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems
QQX
Respiratory Specimen Nucleic Acid Sars-cov-2 Test
320d
Cleared
Oct 20, 2022
BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel
QMV
Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness
209d
Cleared
Oct 13, 2022
VITEK 2 AST-Gram Positive Cefoxitin Screen
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
209d
Cleared
Oct 12, 2022
Elecsys CMV IgG
LFZ
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
197d
Cleared
Oct 12, 2022
Elecsys HSV-1 IgG (08948844160)
MXJ
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
195d
Cleared
Oct 12, 2022
Elecsys HSV-2 IgG (08948887160)
MYF
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
195d
Cleared
Oct 05, 2022
Colibrí System
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
222d
Cleared
Sep 21, 2022
BD MAX Enteric Viral Panel
PCH
Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System
203d
Cleared
Sep 15, 2022
Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30
JTN
Susceptibility Test Discs, Antimicrobial
672d
Cleared
Sep 13, 2022
Simplexa COVID-19 Direct
QQX
Respiratory Specimen Nucleic Acid Sars-cov-2 Test
431d
Cleared
Aug 30, 2022
Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
PBK
Non-variola Orthopoxvirus Real-time Pcr Primer And Probe Set
6d
Cleared
Aug 26, 2022
Dimension EXL LOCI BRAHMS Procalcitonin (PCT)
PRI
Procalcitonin Assay
207d
Cleared
Aug 19, 2022
Viramed Borrela All-In-One ViraChip Test Kit
LSR
Reagent, Borrelia Serological Reagent
226d
Looking for a specific microbiology device? Search by device name, K-number or manufacturer.
Search all Microbiology 510(k) devices