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
5932 Microbiology devices
2651–2675 of 5932
Cleared Mar 06, 1996
SAS SALMONELLA 0 FACTOR FACTOR 5 ANTISERUM
K960163 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 55d
Cleared Mar 06, 1996
SAS SALMONELLA O GROUP T FACTOR 42 ANTISERUM
K960458 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 36d
Cleared Mar 06, 1996
SAS SALMONELLA O GROUP S FACTOR 41 ANTISERUM
K960459 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 36d
Cleared Mar 06, 1996
SAS SALMONELLA O FACTOR 46 ANTISERUM
K960460 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 36d
Cleared Mar 06, 1996
SAS SALMONELLA O GROUP Q FACTOR 39 ANTISERUM
K960462 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 36d
Cleared Mar 06, 1996
SAS SALMONELLA O GROUP U FACTOR 43 ANTISERUM
K960463 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 36d
Cleared Mar 06, 1996
SAS SALMONELLA O GROUP P FACTOR 38 ANTISERUM
K960465 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 36d
Cleared Mar 04, 1996
SAS SALMONELLA H G ANTISERUM
K960131 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 48d
Cleared Mar 04, 1996
SAS SALMONELLA H F ANTISERUM
K960133 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 48d
Cleared Mar 04, 1996
SAS SALMONELLA H Z28 ANTISERUM
K960331 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 40d
Cleared Mar 04, 1996
SAS SALMONELLA H G,P,U ANTISERUM
K960333 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 40d
Cleared Mar 04, 1996
SAS SALMONELLA H POLY A-Z ANTISERUM
K960335 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 40d
Cleared Mar 04, 1996
SAS SALMONELLA H Z23 ANTISERUM
K960603 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 20d
Cleared Mar 04, 1996
SAS SALMONELLA H Z32 ANTISERUM
K960609 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 20d
Cleared Mar 04, 1996
SAS SALMONELLA H Z15 ANTISERUM
K960610 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 20d
Cleared Feb 29, 1996
GIBSON ID-M. CAT.
K955826 · Gibson Laboratories, Inc.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 65d
Cleared Feb 23, 1996
IMMULITE TOXOPLASMA GONDII IGG
K950671 · Diagnostic Products Corp.
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 375d
Cleared Feb 23, 1996
SERAQUEST CMV IGG
K954191 · Quest Intl., Inc.
LFZ · Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus · 170d
Cleared Feb 23, 1996
REMEL CEFEPIME 30 UG SUSCEPTIBILITY DISK
K955669 · Remel Co.
JTN · Susceptibility Test Discs, Antimicrobial · 72d
Cleared Feb 23, 1996
DRIED GRAM-NEGATIVE MIC/COMBO PANELS
K955910 · Dade Microscan, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 56d
Cleared Feb 22, 1996
THE E TEST CEFTIZOXIME
K955920 · Ab Biodisk
JWY · Manual Antimicrobial Susceptibility Test Systems · 113d
Cleared Feb 16, 1996
BACTEC STANDARD/10 AEROBIC/F CULTURE VIALS
K954921 · Becton Dickinson Diagnostic Instrument Systems
MDB · System, Blood Culturing · 113d
Cleared Feb 16, 1996
BACTEC LYTIC/10 ANAEROBIC/F CULTURE VIALS
K954925 · Becton Dickinson Diagnostic Instrument Systems
MDB · System, Blood Culturing · 113d
Cleared Feb 16, 1996
BACTEC PEDS PLUS/F CULTURE VIALS
K954927 · Becton Dickinson Diagnostic Instrument Systems
MDB · System, Blood Culturing · 113d
Cleared Feb 16, 1996
BACTEC CULTURE VIALS, LYTIC, ANAEROBIC
K954930 · Becton Dickinson Diagnostic Instrument Systems
MDB · System, Blood Culturing · 113d

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All categories 5932 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