FDA Review Panel · MI

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

7067
Total
7005
Cleared
149d
Avg (2y)
1976
Since
5931 Microbiology devices
2526–2550 of 5931
Cleared Jul 10, 1996
COPALIS CMV TOTAL ANTIBODY ASSAY
K955799 · Sienna Biotech, Inc.
LJO · Antigen, Iha, Cytomegalovirus · 201d
Cleared Jul 10, 1996
GENTAMICIN DISK (120MCG)
K961818 · Remel, L.P.
JTN · Susceptibility Test Discs, Antimicrobial · 61d
Cleared Jul 10, 1996
STREPTOMYCIN DISK (300MCG)
K961819 · Remel, L.P.
JTN · Susceptibility Test Discs, Antimicrobial · 61d
Cleared Jul 08, 1996
MCCOY CELL CULTURES
K955608 · Vai Diagnostics, Inc.
KIR · Cells, Animal And Human, Cultured · 213d
Cleared Jul 05, 1996
ETEST SUBMISSION FOR CEFOTETAN
K961517 · Ab Biodisk
JWY · Manual Antimicrobial Susceptibility Test Systems · 74d
Cleared Jul 05, 1996
ETEST SUBMISSION FOR AZITHROMYCIN
K961519 · Ab Biodisk
JWY · Manual Antimicrobial Susceptibility Test Systems · 74d
Cleared Jun 27, 1996
ACCUMETER H. PYLORI TEST
K960478 · Chemtrak, Inc.
LYR · Helicobacter Pylori · 146d
Cleared Jun 24, 1996
SYPHILIS IGM HUMAN SERUM CONTROLS
K961317 · Pyramid Biological Corp.
LIP · Enzyme Linked Immunoabsorption Assay, Treponema Pallidum · 80d
Cleared Jun 21, 1996
IMMULITE HERPES I AND II IGG
K950670 · Diagnostic Products Corp.
LGC · Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific · 494d
Cleared Jun 18, 1996
SAS SALMONELLA O FACTOR 20 ANTISERUM
K961948 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 29d
Cleared Jun 18, 1996
SAS SALMONELLA O FACTOR 14 ANTISERUM
K961949 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 29d
Cleared Jun 18, 1996
SAS SALMONELLA O FACTOR 15 ANTISERUM &/OR O GROUP E2 FACTOR 15 ANTISERUM
K961950 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 29d
Cleared Jun 18, 1996
SAS SALMONELLA O FACTOR 6 ANTISERUM
K961951 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 29d
Cleared Jun 18, 1996
SAS SALMONELLA O FACTOR /O GROUP A FACTOR 2 ANTISERUMS
K961952 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 29d
Cleared Jun 18, 1996
SAS SALMONELA H Z24 ANTISERUM
K961953 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 29d
Cleared Jun 18, 1996
SAS SALMONELLA H Z35 ANTISERUM
K961954 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 29d
Cleared Jun 18, 1996
SAS SALMONELLA H Z42 ANTISERUM
K961955 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 29d
Cleared Jun 18, 1996
SAS SALMONELLA H G,M,Q ANTISERMU
K961956 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 29d
Cleared Jun 18, 1996
SAS SALMONELLA H Z4, Z32 ANTISERUM
K961957 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 29d
Cleared Jun 18, 1996
SAS SALMONELLA H Z4 COMPLEX ANTISERUM
K961958 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 29d
Cleared Jun 18, 1996
SAS SALMONELLA H Z4, Z24 ANTISERUM
K961960 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 29d
Cleared Jun 18, 1996
SAS SALMONELLA H F,G,T ANTISERUM
K961961 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 29d
Cleared Jun 18, 1996
SAS SALMONELLA O GROUP V FACTOR 44 ANTISERUM
K961962 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 29d
Cleared Jun 18, 1996
SAS SALMONELLA O GROUP W FACTOR 45 ANTISERUM
K961963 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 29d
Cleared Jun 18, 1996
SAS SALMONELLA O GROUP H FACTORS 14,24,25 ANTISERUM
K961964 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 29d

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All categories 5931 JWY Manual Antimicrobial Susceptibility Test Systems 408 JTN Susceptibility Test Discs, Antimicrobial 316 LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation 284 JSJ Culture Media, Selective And Non-differential 264 JSI Culture Media, Selective And Differential 216 JTO Discs, Strips And Reagents, Microorganism Differentiation 194 JSG Culture Media, Non-selective And Non-differential 181 JSH Culture Media, Non-selective And Differential 115 LSR Reagent, Borrelia Serological Reagent 98 LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii 94 GTZ Antisera, All Groups, Streptococcus Spp. 84 LFX Enzyme Linked Immunoabsorbent Assay, Rubella 79 JSM Culture Media, Non-propagating Transport 77 OCC Respiratory Virus Panel Nucleic Acid Assay System 75 LYR Helicobacter Pylori 75