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
150d
Avg (2y)
1976
Since
5941 Microbiology devices
4601–4625 of 5941
Cleared Jan 07, 1985
THIOGLYCOLLATE W/O INDICATOR
K844536 · bioMerieux, Inc.
JSG · Culture Media, Non-selective And Non-differential · 47d
Cleared Jan 07, 1985
FLUID THIOGLYCOLLATE MEDIUM W/INDICATOR
K844537 · bioMerieux, Inc.
JSG · Culture Media, Non-selective And Non-differential · 47d
Cleared Jan 07, 1985
COOKED MEAT MEDIUM
K844538 · bioMerieux, Inc.
JSG · Culture Media, Non-selective And Non-differential · 47d
Cleared Jan 07, 1985
PHENOL RED BROTH W/CARBOHYDRATES
K844539 · bioMerieux, Inc.
JSF · Culture Media, Single Biochemical Test · 47d
Cleared Jan 07, 1985
CYSTINE TRYPTIC AGAR W/FRUCTOSE
K844540 · bioMerieux, Inc.
JSF · Culture Media, Single Biochemical Test · 47d
Cleared Jan 07, 1985
TRYPTIC SOY BROTH
K844541 · bioMerieux, Inc.
JSG · Culture Media, Non-selective And Non-differential · 47d
Cleared Jan 05, 1985
YERSINIA SELECTIVE AGAR
K844535 · bioMerieux, Inc.
JSI · Culture Media, Selective And Differential · 45d
Cleared Jan 04, 1985
DIRECTIGEN GROUP A STREP TEST KIT
K843713 · Bd Becton Dickinson Vacutainer Systems Preanalytic
GTZ · Antisera, All Groups, Streptococcus Spp. · 105d
Cleared Jan 04, 1985
BBL PORT-A-CUL 21628 DOUBLE SWAB SULTURE COLLECTIO
K844369 · Precision Dynamics Corp.
JSM · Culture Media, Non-propagating Transport · 52d
Cleared Jan 04, 1985
BBL PORT-A-CUL 21627 SINGLE SWAB CULTURE COLLECT
K844370 · Precision Dynamics Corp.
JSM · Culture Media, Non-propagating Transport · 52d
Cleared Jan 04, 1985
BILE DIFFERENTIAL DISK
K844380 · Anaerobe Systems
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 52d
Cleared Jan 04, 1985
COLISTIN 10 MCG. DIFFERENTIAL DISK
K844381 · Anaerobe Systems
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 52d
Cleared Jan 04, 1985
VANCOMYCIN 5MCG DIFFERENTIAL DISK
K844382 · Anaerobe Systems
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 52d
Cleared Jan 04, 1985
KANAMYCIN 1000 MCG DIFFERENTIAL DISK
K844383 · Anaerobe Systems
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 52d
Cleared Jan 04, 1985
VIRAL TRANSPORT MEDIA
K844747 · Hillcrest Biologicals
JSM · Culture Media, Non-propagating Transport · 29d
Cleared Dec 24, 1984
MIC-BIO-PLATE
K844903 · Pasco Laboratories, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 10d
Cleared Dec 14, 1984
API UNISCEPT MIC 100UL
K844159 · Analytical Products, Inc.
LTW · Susceptibility Test Cards, Antimicrobial · 51d
Cleared Dec 13, 1984
PYRIDOXAL DISC
K844020 · Remel Co.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 59d
Cleared Dec 12, 1984
AMS ANA CARD
K843686 · Vitek Systems, Inc.
JSP · Kit, Anaerobic Identification · 85d
Cleared Dec 03, 1984
ENZYGNOST BETA-2 MICROGLOBULIN TEST
K843967 · Behring Diagnostics, Inc.
JZG · System, Test, Beta-2-microglobulin Immunological · 53d
Cleared Nov 27, 1984
PHARMACIA STREP A DIRECT SWAB TEST
K844107 · Pharmacia, Inc.
GTZ · Antisera, All Groups, Streptococcus Spp. · 35d
Cleared Nov 27, 1984
BIOTIS ANAEROBIC KBE AGAR
K844195 · Otisville Biotech, Inc.
JSI · Culture Media, Selective And Differential · 28d
Cleared Nov 13, 1984
POS COMBO PANEL
K844086 · American Micro Scan
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 22d
Cleared Nov 07, 1984
SCEPTOR BETA-LACTAM PLUS MIC PANEL
K844231 · Bd Becton Dickinson Vacutainer Systems Preanalytic
LTW · Susceptibility Test Cards, Antimicrobial · 8d
Cleared Oct 31, 1984
STREP ID TRIPLATE
K844019 · Remel Co.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 16d

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All categories 5941 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 99 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