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
5943 Microbiology devices
4826–4850 of 5943
Cleared Feb 27, 1984
MYCOLOGICAL SELECTIVE MEDIUM
K840520 · Scientific Device Laboratory, Inc.
JSJ · Culture Media, Selective And Non-differential · 21d
Cleared Feb 27, 1984
BLOOD AGAR W/AMPICILLIN
K840554 · Remel Co.
JSJ · Culture Media, Selective And Non-differential · 19d
Cleared Feb 27, 1984
SPOTTEST OXIDASE REAGENT
K840575 · Difco Laboratories, Inc.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 19d
Cleared Feb 27, 1984
SPOTTEST DMACA INDOLE REAGENT
K840576 · Difco Laboratories, Inc.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 19d
Cleared Feb 27, 1984
SPOTTEST KOVACS' INDOLE REAGENT
K840577 · Difco Laboratories, Inc.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 19d
Cleared Feb 27, 1984
SPOTTEST VOGES-PROSKAUER REAGENT A
K840578 · Difco Laboratories, Inc.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 19d
Cleared Feb 27, 1984
SPOTTEST NITRATE REAGENT A
K840579 · Difco Laboratories, Inc.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 19d
Cleared Feb 27, 1984
SPOTTEST NITRATE REAGENT B
K840580 · Difco Laboratories, Inc.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 19d
Cleared Feb 27, 1984
SPOTTEST NITRATE REAGENT C
K840581 · Difco Laboratories, Inc.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 19d
Cleared Feb 27, 1984
SPOTTEST FERRIC CHLORIDE REAGENT
K840582 · Difco Laboratories, Inc.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 19d
Cleared Feb 27, 1984
SPOTTEST VOGES-PROSKAUER REAGENT B
K840583 · Difco Laboratories, Inc.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 19d
Cleared Feb 24, 1984
VIRAL TRANSPORT MEDIUM
K840851 · Bartels Immunodiagnostic Supplies, Inc.
Cleared Feb 17, 1984
MACCONKEY AGAR W/TWEEN 80 & AMPICIL
K840190 · Remel Co.
JSI · Culture Media, Selective And Differential · 30d
Cleared Feb 17, 1984
GROUP A SELECTIVE AGAR W/5% SHEEP BLOOD
K840294 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JSI · Culture Media, Selective And Differential · 24d
Cleared Feb 13, 1984
CHLAMYDIAE ISOLATION MEDIUM W/CYCLOHEX
K834122 · Bartels Immunodiagnostic Supplies, Inc.
KIT · Media And Components, Synthetic Cell And Tissue Culture · 76d
Cleared Feb 13, 1984
CHLAMYDIAL TRANSPORT MEDIUM
K834125 · Bartels Immunodiagnostic Supplies, Inc.
JSM · Culture Media, Non-propagating Transport · 76d
Cleared Feb 13, 1984
DIFFERENTIATION DISKS HIPPURATE
K834581 · Difco Laboratories, Inc.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 46d
Cleared Feb 13, 1984
CHOCOLATE AGAR GC BASE PLATE
K840065 · Otisville Biotech, Inc.
JTY · Culture Media, For Isolation Of Pathogenic Neisseria · 35d
Cleared Feb 13, 1984
CHOCOLATE AGAR MUELLERH-HINTON BASE
K840066 · Otisville Biotech, Inc.
JTZ · Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth · 35d
Cleared Feb 13, 1984
THAYER-MARTIN AGAR PLATE
K840067 · Otisville Biotech, Inc.
JTY · Culture Media, For Isolation Of Pathogenic Neisseria · 35d
Cleared Feb 13, 1984
KV BLOOD AGAR PLATE
K840074 · Otisville Biotech, Inc.
JSJ · Culture Media, Selective And Non-differential · 35d
Cleared Feb 13, 1984
GN BROTH TUBE
K840076 · Otisville Biotech, Inc.
JSJ · Culture Media, Selective And Non-differential · 35d
Cleared Feb 10, 1984
PRESERV GOMORI TRICHROME STAIN 125/500
K840087 · Preventive Diagnostics Corp.
LED · Stains, Chemical Solution · 31d
Cleared Feb 04, 1984
PRESERV SAF FIXATIVE 15ML
K834566 · Preventive Diagnostics Corp.
LIO · Device, Specimen Collection · 38d
Cleared Feb 03, 1984
CONTACT-K APTT REAGENT
K834086 · Pacific Hemostasis
GGN · Plasma, Coagulation Control · 67d

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All categories 5943 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 LYR Helicobacter Pylori 75 OCC Respiratory Virus Panel Nucleic Acid Assay System 75