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
4726–4750 of 5943
Cleared May 11, 1984
PRESTON CAMPYLOBACTER SELECTIVE SUPP
K840330 · Oxoid U.S.A., Inc.
JSK · Supplement, Culture Media · 107d
Cleared May 11, 1984
LEGIONELLA MWY SELECTIVE SUPPLEMENT
K840331 · Oxoid U.S.A., Inc.
JSK · Supplement, Culture Media · 107d
Cleared May 11, 1984
CAMPYLOBACTER AGAR BASE
K840332 · Oxoid U.S.A., Inc.
JSJ · Culture Media, Selective And Non-differential · 107d
Cleared May 11, 1984
LEGIONELLA BMPA SELECTIVE SUPPLE
K840333 · Oxoid U.S.A., Inc.
JSK · Supplement, Culture Media · 107d
Cleared May 11, 1984
KF STREPTOCOCCUS AGAR
K841658 · Oxoid U.S.A., Inc.
JSJ · Culture Media, Selective And Non-differential · 18d
Cleared May 11, 1984
SYNTHETIC BROTH A.O.A.C.
K841661 · Oxoid U.S.A., Inc.
JST · Kit, Fastidious Organisms · 18d
Cleared May 09, 1984
PHAMAS ALLERGY MGMT. SYSTEM
K841915 · Pharmacia, Inc.
Cleared May 07, 1984
MICROTRAK HSV 1 & 2 CULTURE
K840494 · Syva Co.
GQL · Antisera, Fluorescent, Herpesvirus Hominis 1,2 · 91d
Cleared May 07, 1984
MUELLER-HINTON BROTH
K841560 · Gibco Laboratories Life Technologies, Inc.
JTZ · Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth · 20d
Cleared May 02, 1984
CYTOMEGALOVIRUS ANTIBODY FLUORO-KIT II
K833089 · Clinical Sciences, Inc.
GQH · Antigen, Cf (including Cf Control), Cytomegalovirus · 233d
Cleared May 02, 1984
HSV ANTIGEN ELISA KIT
K834449 · Ortho Diagnostic Systems, Inc.
LGC · Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific · 135d
Cleared May 02, 1984
DIRECTIGEN MENNINGITIS TEST KIT
K841308 · Bd Becton Dickinson Vacutainer Systems Preanalytic
GTI · Antisera, Fluorescent, All Groups, N. Meningitidis · 33d
Cleared May 02, 1984
RIM ONPG KIT
K841329 · Austin Biological Laboratories
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 30d
Cleared May 02, 1984
WELLCOGEN S. PNEUMONIAE
K841376 · Wellcome Diagnostics
GWC · Antisera, All Types, Streptococcus Pneumoniae · 29d
Cleared May 02, 1984
RIM-DNASE KIT
K841389 · Austin Biological Laboratories
JSF · Culture Media, Single Biochemical Test · 29d
Cleared May 02, 1984
DIFFERENTIATION DISKS SPECTINOMYCIN
K841453 · Difco Laboratories, Inc.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 23d
Cleared May 02, 1984
RIM GARDNERELLA VAGINALIS KIT
K841460 · Austin Biological Laboratories
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 23d
Cleared Apr 24, 1984
TOXOPLASMA GOND II IGG DIA TEST KIT
K833829 · Labsystems, Inc.
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 173d
Cleared Apr 20, 1984
DEAE-DEXTRAN IN PBS
K834116 · Bartels Immunodiagnostic Supplies, Inc.
KIT · Media And Components, Synthetic Cell And Tissue Culture · 143d
Cleared Apr 20, 1984
RIM-BILE ESCULIN TEST
K841262 · Austin Biological Laboratories
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 25d
Cleared Apr 20, 1984
RIM - NITRATE TEST
K841270 · Austin Biological Laboratories
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 24d
Cleared Apr 20, 1984
RIM-HIPPURATE
K841277 · Austin Biological Laboratories
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 23d
Cleared Apr 20, 1984
RIM 6.5% NACL
K841508 · Austin Biological Laboratories
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 9d
Cleared Apr 18, 1984
PHADEBAS RAST PHADEZYM MIX ALLERG
K840670 · Pharmacia, Inc.
DHB · System, Test, Radioallergosorbent (rast) Immunological · 57d
Cleared Apr 17, 1984
HAEMOPHILUS I.D. II TRIPLATE
K840338 · Remel Co.
JSI · Culture Media, Selective And Differential · 83d

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