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
4201–4225 of 5941
Cleared May 20, 1986
GENTAMICIN SULFATE SOLUTION (50MG GENTAMICIN)
K861823 · Flow Laboratories, Inc.
JSK · Supplement, Culture Media · 8d
Cleared May 20, 1986
GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN)
K861824 · Flow Laboratories, Inc.
JSK · Supplement, Culture Media · 8d
Cleared May 16, 1986
REGAN-LOWE AGAR
K861734 · Gibco Laboratories Life Technologies, Inc.
JSJ · Culture Media, Selective And Non-differential · 10d
Cleared May 13, 1986
CYTOMEGALOVIRUS DIRECT FLUORESCENT ANTIBODY KIT
K860279 · Bartels Immunodiagnostic Supplies, Inc.
LIN · Antisera, Conjugated Fluorescent, Cytomegalovirus · 119d
Cleared May 13, 1986
YEAST IDENTIFICATION PANEL
K860575 · American Micro Scan
JXB · Kit, Identification, Yeast · 84d
Cleared May 13, 1986
DIRECTIGEN COMBO MENINGITIS TEST
K860768 · Bd Becton Dickinson Vacutainer Systems Preanalytic
GTZ · Antisera, All Groups, Streptococcus Spp. · 71d
Cleared May 13, 1986
LEECO-SCREEN, STREP A (EIA)
K860947 · Leeco Diagnostics, Inc.
GTZ · Antisera, All Groups, Streptococcus Spp. · 62d
Cleared May 06, 1986
SENSITITRE SUSCEPTIBILITY PLATES
K860753 · Gibco Laboratories Life Technologies, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 68d
Cleared May 06, 1986
CHARCOAL AGAR BASE
K861480 · Gibco Laboratories Life Technologies, Inc.
JSG · Culture Media, Non-selective And Non-differential · 14d
Cleared May 01, 1986
CORDOT R
K854618 · Cordis Corp.
LFX · Enzyme Linked Immunoabsorbent Assay, Rubella · 164d
Cleared Apr 28, 1986
CHLAMYSET ANTIGEN
K853401 · Orion Corp.
LJP · Antiserum, Fluorescent, Chlamydia Trachomatis · 259d
Cleared Apr 21, 1986
CORDIA CMV-M
K853889 · Cordis Corp.
LKQ · Antibody Igm,if, Cytomegalovirus Virus · 214d
Cleared Apr 11, 1986
FOX FASTIDIOUS TEST PANEL
K854525 · Beckman Instruments, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 149d
Cleared Apr 11, 1986
CEFOTETAN 30 MCG ANTIMICROBIAL SUSCEPTIBILITY DISK
K860895 · Organon Teknika Corp.
JTN · Susceptibility Test Discs, Antimicrobial · 32d
Cleared Apr 11, 1986
MACCONKEY W/MUG
K861259 · Remel Co.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 8d
Cleared Apr 07, 1986
CELLEMATICS VIRAL/CHLAMYDAL TRANSPORT PACK(MODIFI)
K861080 · Difco Laboratories, Inc.
JSM · Culture Media, Non-propagating Transport · 17d
Cleared Apr 04, 1986
TANDEM ICON STREP A IMMUNOENZYMETRIC ASSAY KIT
K860778 · Hybritech, Inc.
GTZ · Antisera, All Groups, Streptococcus Spp. · 32d
Cleared Apr 04, 1986
URICHECK
K860905 · Difco Laboratories, Inc.
JXA · Kit, Screening, Urine · 25d
Cleared Mar 19, 1986
MICRO-MEDIA MICRODILUTION TEST PANELS
K853805 · Beckman Instruments, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 189d
Cleared Mar 18, 1986
DIFCO STREP A LATEX TEST
K854978 · Difco Laboratories, Inc.
GTZ · Antisera, All Groups, Streptococcus Spp. · 96d
Cleared Mar 18, 1986
CAMPYLOBACTER CVA AGAR
K860862 · Gibco Laboratories Life Technologies, Inc.
JSJ · Culture Media, Selective And Non-differential · 11d
Cleared Mar 14, 1986
MCBRIDE LISTERIA AGAR
K860861 · Gibco Laboratories Life Technologies, Inc.
JSJ · Culture Media, Selective And Non-differential · 7d
Cleared Mar 12, 1986
RUBALEX
K852788 · Orion Corp.
LQN · Latex Agglutination Assay, Rubella · 254d
Cleared Mar 12, 1986
GIBCO MYCOTECT KIT (CATALOG NO. 189-5672)
K860695 · Gibco Laboratories Life Technologies, Inc.
KIW · Kit, Mycoplasma Detection · 15d
Cleared Mar 11, 1986
OXOID STREPTOCOCAL GROUPING KIT
K854929 · Oxoid U.S.A., Inc.
GTZ · Antisera, All Groups, Streptococcus Spp. · 91d

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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