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
5939 Microbiology devices
3526–3550 of 5939
Cleared Feb 07, 1989
MODIFIED LABYSYSTEMS' TOXOPLASMA GONDII IGG EIA
K890154 · Labsystems, Inc.
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 26d
Cleared Feb 07, 1989
DIFCO DIRECTOR INOCULATION SYSTEM
K890339 · Difco Laboratories, Inc.
LIE · Reagent/device, Inoculum Calibration · 15d
Cleared Feb 03, 1989
ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KIT
K884026 · Oxoid U.S.A., Inc.
GNA · Antisera, All Types, Escherichia Coli · 133d
Cleared Feb 03, 1989
PF TEST
K884513 · Medi-Tech, Inc.
GMZ · Antigens, All Types, Escherichia Coli · 99d
Cleared Feb 03, 1989
IMMUNODOT TORCH TEST RUBELLA
K884898 · General Biometrics, Inc.
LFX · Enzyme Linked Immunoabsorbent Assay, Rubella · 72d
Cleared Feb 03, 1989
MODIFIED LABSYSTEMS' RUBELLA IGG EIA TEST KIT
K890091 · Labsystems, Inc.
LFX · Enzyme Linked Immunoabsorbent Assay, Rubella · 29d
Cleared Feb 02, 1989
ORTHO RESULT PLUS/RUBELLA RAPID COLOR. IMMUNOASSAY
K884617 · Ortho Diagnostic Systems, Inc.
LFX · Enzyme Linked Immunoabsorbent Assay, Rubella · 90d
Cleared Feb 02, 1989
IMMUNODOT RUBELLA TEST
K885082 · General Biometrics, Inc.
LFX · Enzyme Linked Immunoabsorbent Assay, Rubella · 55d
Cleared Jan 31, 1989
RUBENOSTIKA(TM) IGM MICROELISA SYSTEM
K882999 · Organon Teknika Corp.
LFX · Enzyme Linked Immunoabsorbent Assay, Rubella · 197d
Cleared Jan 24, 1989
ROTACUBE
K884017 · Difco Laboratories, Inc.
LIQ · Enzyme Linked Immunoabsorbent Assay, Rotavirus · 124d
Cleared Jan 24, 1989
EBV-VCA ANTIBODY (IGG)
K884591 · Hillcrest Biologicals
GNP · Antiserum, Cf, Epstein-barr Virus · 82d
Cleared Jan 13, 1989
LYME FAST TEST
K883544 · 3M Company
LSR · Reagent, Borrelia Serological Reagent · 147d
Cleared Jan 13, 1989
FITC MURINE MONOCLONAL ANTI-RSV IGG
K884516 · Whittaker Bioproducts, Inc.
GQG · Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus · 78d
Cleared Jan 04, 1989
ORTHO* ROTAVIRUS ANTIGEN ELISA TEST
K883935 · Ortho Diagnostic Systems, Inc.
LIQ · Enzyme Linked Immunoabsorbent Assay, Rotavirus · 107d
Cleared Jan 04, 1989
ORTHO* ROTAVIRUS LATEX AGGLUTINATION TEST
K883940 · Ortho Diagnostic Systems, Inc.
LIQ · Enzyme Linked Immunoabsorbent Assay, Rotavirus · 107d
Cleared Dec 22, 1988
ORTHO* SYPHILIS-M ANTIBODY ELISA TEST
K883938 · Ortho Diagnostic Systems, Inc.
LIP · Enzyme Linked Immunoabsorption Assay, Treponema Pallidum · 94d
Cleared Dec 22, 1988
ORTHO* SYPHILIS-G ANTIBODY ELISA TEST
K883939 · Ortho Diagnostic Systems, Inc.
LIP · Enzyme Linked Immunoabsorption Assay, Treponema Pallidum · 94d
Cleared Dec 16, 1988
CHLAMYDIAZYME/COMMANDER INSTRUMENTATION
K885006 · Abbott Laboratories
LJC · Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) · 14d
Cleared Dec 15, 1988
EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN ANTIBODY TEST
K882440 · Zeus Scientific, Inc.
LLM · Test, Antigen, Nuclear, Epstein-barr Virus · 184d
Cleared Dec 15, 1988
EPSTEIN-BARR VIRUS EARLY ANTIGEN (EA) ANTIBODY TES
K882447 · Zeus Scientific, Inc.
LSE · Epstein-barr Virus, Other · 184d
Cleared Dec 13, 1988
LYME DISEASE IFA (IGG)
K883487 · Hillcrest Biologicals
LSR · Reagent, Borrelia Serological Reagent · 119d
Cleared Dec 13, 1988
WASHER 500 MICROELISA SYSTEM
K884695 · Organon Teknika Corp.
JTC · Device, Microtiter Diluting/dispensing · 34d
Cleared Dec 08, 1988
MODIFIED IDEIA CHLAMYDIA TEST
K880799 · Boots-Celltech Diagnostics, Inc.
LJC · Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) · 283d
Cleared Dec 05, 1988
RUBEOLA TEST
K884004 · Gull Laboratories, Inc.
GRE · Antiserum, Fluorescent, Rubeola · 75d
Cleared Dec 05, 1988
MODIFIED CELL-MATICS HERPES SIMPLEX VIRUS DETECT.
K884761 · Difco Laboratories, Inc.
GQN · Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 · 21d

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All categories 5939 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