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, 2023
BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit
PSZ
Devices Detecting Influenza A, B, And C Virus Antigens
120d
Cleared
Jan 26, 2023
Revogene
OOI
Real Time Nucleic Acid Amplification System
134d
Cleared
Jan 20, 2023
The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml
NGZ
Susceptibility Test Plate, Antifungal
204d
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 09, 2022
LIAISON Anti-HAV
LOL
Hepatitis A Test (antibody And Igm Antibody)
30d
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 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
Sep 21, 2022
BD MAX Enteric Viral Panel
PCH
Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System
203d
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
BD MAX Enteric Parasite Panel
PCH
Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System
207d
Cleared
Aug 08, 2022
VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 µg/mL)
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
385d
Cleared
Jul 28, 2022
BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel
PCI
Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-based Assay System
210d
Cleared
Jul 14, 2022
LIAISON MeMed BV, LIAISON MeMed BV Control Set
QPS
Immunoassay For Host Biomarkers Of Infection
210d
Cleared
Jul 12, 2022
VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
210d
Cleared
Jul 11, 2022
Revogene
OOI
Real Time Nucleic Acid Amplification System
143d
Cleared
Jul 06, 2022
cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System
OCC
Respiratory Virus Panel Nucleic Acid Assay System
210d
Cleared
Jun 24, 2022
Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
PBK
Non-variola Orthopoxvirus Real-time Pcr Primer And Probe Set
1d
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