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
5931 Microbiology devices
2601–2625 of 5931
Cleared May 06, 1996
LCX NEISSERIA GONORRHOEAE ASSAY
K935833 · Abbott Laboratories
LSL · Dna-reagents, Neisseria · 881d
Cleared May 03, 1996
IMMUNO DOT BORRELIA DOT BLOT G TEST
K953682 · Genbio
LSR · Reagent, Borrelia Serological Reagent · 270d
Cleared May 03, 1996
MMUNO DOT BORRELIA DOT BLOT M TEST
K953683 · Genbio
LSR · Reagent, Borrelia Serological Reagent · 270d
Cleared Apr 29, 1996
EBNA IGG EIA TEST SYSTEM
K951549 · Immunoprobe, Inc.
LLM · Test, Antigen, Nuclear, Epstein-barr Virus · 391d
Cleared Apr 26, 1996
CEFEPIME DISPANS-O-DISC (CEFEPLIME - 30MCG)
K961148 · Difco Laboratories, Inc.
JTW · System, Transport, Aerobic · 36d
Cleared Apr 18, 1996
IMMUNOCARD TOXIN A
K955859 · Meridian Diagnostics, Inc.
LLH · Reagents, Clostridium Difficile Toxin · 113d
Cleared Apr 18, 1996
M. CAT BUTYRATE DISK
K960996 · Hardy Diagnostics
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 37d
Cleared Apr 15, 1996
RUBELLA IGG ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC DEVICE
K951359 · Bayer Corp.
LFX · Enzyme Linked Immunoabsorbent Assay, Rubella · 385d
Cleared Apr 15, 1996
CARDS Q.S. STREP A
K955108 · Quidel Corp.
GTZ · Antisera, All Groups, Streptococcus Spp. · 159d
Cleared Apr 10, 1996
HAEMOPHILUS TEST MEDIUM (HTM)
K952595 · Clinical Standards Laboratories, Inc.
JSO · Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar · 309d
Cleared Apr 09, 1996
ACCESS RUBELLA IGG
K954687 · Bio-Rad Laboratories, Inc.
LFX · Enzyme Linked Immunoabsorbent Assay, Rubella · 181d
Cleared Apr 09, 1996
SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES
K960366 · Accumed Intl., Inc.
LTT · Panels, Test, Susceptibility, Antimicrobial · 75d
Cleared Apr 05, 1996
CEFEPIME, 30 MCG, SENSI-DISC
K961188 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JTN · Susceptibility Test Discs, Antimicrobial · 10d
Cleared Apr 04, 1996
MUELLER HINTON AGAR WITH 5% SHEEP BLOOD
K960420 · Becton Dickinson Microbiology Systems
JTZ · Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth · 66d
Cleared Apr 03, 1996
STARSWAB CULTURE COLLECTION AND TRANSPORT SYSTEM
K960997 · Starplex Scientific, Inc.
LIO · Device, Specimen Collection · 22d
Cleared Mar 27, 1996
SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES
K960235 · Accumed Intl., Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 70d
Cleared Mar 25, 1996
MUELLER HINTON AGAR WITH 2% NACI
K960313 · Remel, L.P.
JTZ · Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth · 63d
Cleared Mar 22, 1996
BINAX STREP A TEST
K960712 · Binax, Inc.
GTZ · Antisera, All Groups, Streptococcus Spp. · 30d
Cleared Mar 20, 1996
VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY
K951799 · Light Diagnostics
GQX · Antiserum, Cf, Varicella-zoster · 336d
Cleared Mar 19, 1996
CALCOFLUOR WHITE STAIN KIT
K960090 · Remel Co.
JTS · Stains, Microbiologic · 68d
Cleared Mar 19, 1996
BACTIDROP CALCOFLUOR WHITE
K960095 · Remel Co.
JTS · Stains, Microbiologic · 68d
Cleared Mar 14, 1996
VARICELISA, MODIFICATION
K943843 · Biowhittaker Molecular Applications, Inc.
LFY · Enzyme Linked Immunoabsorbent Assay, Varicella-zoster · 595d
Cleared Mar 12, 1996
VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI)
K952095 · Biomerieux Vitek, Inc.
LQL · Gram Positive Identification Panel · 313d
Cleared Mar 12, 1996
SAS SALMONELLA O GROUP Y FACTOR 48 ANTISERUM
K960129 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 61d
Cleared Mar 12, 1996
SAS SALMONELLA O GROUP Z FACTOR 50 ANTISERUM
K960130 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 61d

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All categories 5931 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 98 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