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
4101–4125 of 5941
Cleared Nov 04, 1986
DIAGNOSTIC REAGENT SET-RPLA
K855233 · Oxoid U.S.A., Inc.
GTN · Antisera, Fluorescent, All Types, Staphylococcus Spp. · 308d
Cleared Nov 04, 1986
DIAGNOSTIC REAGENT VET-RPLA
K855234 · Oxoid U.S.A., Inc.
GNA · Antisera, All Types, Escherichia Coli · 308d
Cleared Nov 04, 1986
DIAGNOSTIC REAGENT PET-RPLA
K855235 · Oxoid U.S.A., Inc.
JSP · Kit, Anaerobic Identification · 308d
Cleared Nov 04, 1986
DIAGNOSTIC REAGENT TST-RPLA
K855236 · Oxoid U.S.A., Inc.
GTN · Antisera, Fluorescent, All Types, Staphylococcus Spp. · 308d
Cleared Oct 31, 1986
CANDIDA BROM CRESOL GREEN AGAR
K864077 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JSI · Culture Media, Selective And Differential · 11d
Cleared Oct 31, 1986
MODIFIED N.Y.C. FERMENTATION MEDIUM BASE
K864078 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JTY · Culture Media, For Isolation Of Pathogenic Neisseria · 11d
Cleared Oct 31, 1986
TRYCOPHYTON AGARS
K864100 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JSH · Culture Media, Non-selective And Differential · 10d
Cleared Oct 29, 1986
THE WELLCOME ROTAVIRUS LATEX TEST ZL40
K861634 · Wellcome Diagnostics
LIQ · Enzyme Linked Immunoabsorbent Assay, Rotavirus · 183d
Cleared Oct 29, 1986
LOMBARD DOWELL AGAR BASE
K864014 · Gibco Laboratories Life Technologies, Inc.
KZI · Culture Media, Enriched · 14d
Cleared Oct 22, 1986
PATHFINDER ROTAVIRUS CHEMILUMINESCENT
K862917 · Kallestad Laboratories, Inc.
LIQ · Enzyme Linked Immunoabsorbent Assay, Rotavirus · 82d
Cleared Oct 10, 1986
PATHFINDER(TM) SPECIMEN COLLECTION KIT
K863682 · Kallestad Laboratories, Inc.
JSM · Culture Media, Non-propagating Transport · 21d
Cleared Oct 09, 1986
AMEBIASIS MICROASSAY
K863811 · Diamedix Corp.
KHW · Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. · 9d
Cleared Oct 09, 1986
MUELLER HINTON AGAR W/4%NACL AND OXACILLIN
K863821 · Gibco Laboratories Life Technologies, Inc.
JTZ · Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth · 9d
Cleared Oct 08, 1986
DRI-FORM: GBNA LISTERIA MEDIUM NO. M22300
K863820 · Gibco Laboratories Life Technologies, Inc.
JSJ · Culture Media, Selective And Non-differential · 8d
Cleared Oct 01, 1986
CYTOMEGALOVIRUS IGG EIA TEST KIT
K862705 · Labsystems, Inc.
GQI · Antiserum, Cf, Cytomegalovirus · 77d
Cleared Sep 30, 1986
GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL
K863038 · American Micro Scan
LQL · Gram Positive Identification Panel · 49d
Cleared Sep 30, 1986
XANTHINE/TYROSINE/CASEIN AGAR
K863572 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JSH · Culture Media, Non-selective And Differential · 18d
Cleared Sep 30, 1986
BIRD SEED AGAR
K863573 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JSH · Culture Media, Non-selective And Differential · 18d
Cleared Sep 30, 1986
STARCH AGAR W/BROM CRESOL PURPLE
K863599 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JSH · Culture Media, Non-selective And Differential · 15d
Cleared Sep 30, 1986
MOTILITY INDOLE LYSINE SULFIDE (MILS) MEDIUM
K863600 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JSH · Culture Media, Non-selective And Differential · 15d
Cleared Sep 30, 1986
ONPG SOLUTION
K863601 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 15d
Cleared Sep 30, 1986
BUFFERED GLYCEROL SALINE
K863602 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JSM · Culture Media, Non-propagating Transport · 15d
Cleared Sep 30, 1986
GI MOTILITY TEST MEDIUM W/TTC
K863603 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JSS · Kit, Identification, Enterobacteriaceae · 15d
Cleared Sep 29, 1986
PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUS
K862743 · Kallestad Laboratories, Inc.
GQG · Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus · 70d
Cleared Sep 19, 1986
CAL (CELLOBIOSE-ARGININE-LYSINE) AGAR
K863519 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JSI · Culture Media, Selective And Differential · 9d

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