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

7095
Total
7032
Cleared
150d
Avg (2y)
1976
Since
7095 Microbiology devices
2501–2525 of 7095
Cleared Aug 20, 1997
IMMUNOCARD STAT! ROTAVIRUS
K971585 · Meridian Diagnostics, Inc.
LIQ · Enzyme Linked Immunoabsorbent Assay, Rotavirus · 111d
Cleared Aug 20, 1997
CLARITHROMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K971638 · Oxoid , Ltd.
JTN · Susceptibility Test Discs, Antimicrobial · 110d
Cleared Aug 20, 1997
COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL
K972448 · Copan Italia Spa
JSL · Culture Media, Anaerobic Transport · 51d
Cleared Aug 20, 1997
COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOAL
K972449 · Copan Italia Spa
JSL · Culture Media, Anaerobic Transport · 51d
Cleared Aug 20, 1997
PASCO MIC AND MIC/ID PANELS
K972567 · Pasco Laboratories, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 50d
Cleared Aug 15, 1997
PASCO MIC AND MIC/ID PANELS
K971951 · Pasco Laboratories, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 79d
Cleared Aug 13, 1997
TICARCILLIN/CLAVULANIC ACID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K971632 · Oxoid , Ltd.
JTN · Susceptibility Test Discs, Antimicrobial · 103d
Cleared Aug 13, 1997
ABBOTT STREP A CONTROLS
K972182 · Abbott Diagnostics
MJZ · Kit, Direct Antigen, Positive Control · 76d
Cleared Aug 12, 1997
ACCURUN 121 HAV IGM POSITIVE CONTROL
K971657 · Boston Biomedica, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 98d
Cleared Aug 12, 1997
ACCURUN 117 HBEAG POSITIVE CONTROL
K972048 · Boston Biomedica, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 71d
Cleared Aug 12, 1997
CHLAMYDIATROL AG
K972129 · Blackhawk Biosystems, Inc.
MJZ · Kit, Direct Antigen, Positive Control · 67d
Cleared Aug 08, 1997
ROTAVIRUS EIA
K964424 · Trinity Biotech, Inc.
LIQ · Enzyme Linked Immunoabsorbent Assay, Rotavirus · 276d
Cleared Aug 08, 1997
BACTEC MYCO/F-SPUTA CULTURE VIALS
K972758 · Becton Dickinson Microbiology Systems
MDB · System, Blood Culturing · 53d
Cleared Aug 07, 1997
ACCURUN 120 HAV IGG POSITIVE CONTROL
K971406 · Boston Biomedica, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 113d
Cleared Aug 07, 1997
ACCURUN 119 ANTI-HEPATITIS B E ANTIGEN (ANTI-HBE) POSITIVE CONTROL
K972307 · Boston Biomedica, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 49d
Cleared Aug 01, 1997
DRIED GRAM-NEGATIVE MIC/COMBO PANELS
K972180 · Dade Microscan, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 52d
Cleared Aug 01, 1997
MODIFICATION OF EST CULTURE SYSTEM II - MYCO
K972756 · Accumed Intl., Inc.
MDB · System, Blood Culturing · 63d
Cleared Jul 28, 1997
FOSFOMYCIN, 200 MG, SENSI-DISC
K972098 · Becton Dickinson Microbiology Systems
JTN · Susceptibility Test Discs, Antimicrobial · 54d
Cleared Jul 23, 1997
STREP A OIA MAX
K962060 · Biostar, Inc.
GTZ · Antisera, All Groups, Streptococcus Spp. · 421d
Cleared Jul 22, 1997
TOX A/B TEST
K971182 · Techlab, Inc.
LLH · Reagents, Clostridium Difficile Toxin · 113d
Cleared Jul 22, 1997
QUANTA LITE RUBEOLA (MEASLES) IGG
K971620 · Inova Diagnostics, Inc.
LJB · Enzyme Linked Immunoabsorbent Assay, Rubeola Igg · 82d
Cleared Jul 14, 1997
MYCOPLASMA IGG ELISA TEST SYSTEM
K971393 · Immunoprobe, Inc.
LJZ · Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. · 96d
Cleared Jul 14, 1997
ETEST FOR LEVOFLOXACIN
K971697 · Ab Biodisk
JWY · Manual Antimicrobial Susceptibility Test Systems · 67d
Cleared Jul 08, 1997
QUALITROL UNASSAYED H. PYLORI CONTROL SET POSITIVE AND NEGATIVE CONTROLS
K972146 · Consolidated Technologies, Inc.
LYR · Helicobacter Pylori · 29d
Cleared Jul 07, 1997
BIOSIGN STREP A - DIRECT STREP A ANTIGEN TEST
K971349 · Princeton BioMeditech Corp.
GTY · Antigens, All Groups, Streptococcus Spp. · 88d

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All categories 7095 JWY Manual Antimicrobial Susceptibility Test Systems 441 JTN Susceptibility Test Discs, Antimicrobial 323 JSJ Culture Media, Selective And Non-differential 299 LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation 291 JSI Culture Media, Selective And Differential 267 JTO Discs, Strips And Reagents, Microorganism Differentiation 239 JSG Culture Media, Non-selective And Non-differential 198 JSH Culture Media, Non-selective And Differential 142 LSR Reagent, Borrelia Serological Reagent 112 JSM Culture Media, Non-propagating Transport 110 LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii 104 GTZ Antisera, All Groups, Streptococcus Spp. 99 LFX Enzyme Linked Immunoabsorbent Assay, Rubella 92 LYR Helicobacter Pylori 91 JSF Culture Media, Single Biochemical Test 87