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
5001–5025 of 5943
Cleared Sep 12, 1983
SEED AGAR
K832577 · Acumedia Manufacturers, Inc.
JSA · Culture Media, Antibiotic Assay · 41d
Cleared Sep 01, 1983
ROGOSA BROTH
K832310 · Oxoid U.S.A., Inc.
JSD · Culture Media, Selective Broth · 49d
Cleared Sep 01, 1983
TCBS AGAR
K832365 · Granite Diagnostics, Inc.
JSI · Culture Media, Selective And Differential · 45d
Cleared Aug 26, 1983
ONPG DISCS
K832307 · Oxoid U.S.A., Inc.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 43d
Cleared Aug 24, 1983
SPS DISCS
K832305 · Oxoid U.S.A., Inc.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 41d
Cleared Aug 24, 1983
BILE AESCULIN DISCS
K832306 · Oxoid U.S.A., Inc.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 41d
Cleared Aug 12, 1983
API UNISCEPT PLUS 140 INOCULATOR
K831462 · Analytical Products, Inc.
JTC · Device, Microtiter Diluting/dispensing · 98d
Cleared Aug 12, 1983
RIM-HAEMOPHILUS 1 & 2
K832051 · Austin Biological Laboratories
JST · Kit, Fastidious Organisms · 49d
Cleared Aug 12, 1983
BBL ANAGEL POWDER
K832229 · Bd Becton Dickinson Vacutainer Systems Preanalytic
KZJ · Device, Gas Generating · 32d
Cleared Aug 12, 1983
RIM-HAEMOPHILUS 2
K832239 · Austin Biological Laboratories
JST · Kit, Fastidious Organisms · 46d
Cleared Aug 11, 1983
MERITEC-STREP GROUP A BETA-HEMOLYTIC
K831599 · Meridian Diagnostics, Inc.
GTY · Antigens, All Groups, Streptococcus Spp. · 86d
Cleared Aug 11, 1983
ANTIBODY TO RESPIRATORY SYNCYTIAL VIRUS
K831924 · Electro-Nucleonics Laboratories, Inc.
LKT · Respiratory Syncytial Virus, Antigen, Antibody, Ifa · 57d
Cleared Jul 28, 1983
LYOPHILIZED MICROORGANISMS
K831653 · Austin Biological Laboratories
JTR · Kit, Quality Control For Culture Media · 66d
Cleared Jul 28, 1983
MODIFIED SOYBEAN CASEIN DIGEST BROTH
K831671 · Isle Media and Sterile Products, Inc.
JSG · Culture Media, Non-selective And Non-differential · 66d
Cleared Jul 26, 1983
EGG YOLK AGAR
K831827 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JSH · Culture Media, Non-selective And Differential · 49d
Cleared Jul 18, 1983
HSV IGM TEST
K830865 · Gull Laboratories, Inc.
GQL · Antisera, Fluorescent, Herpesvirus Hominis 1,2 · 122d
Cleared Jul 07, 1983
INDIRECT FLUORO-KIT HSV
K830623 · Clinical Sciences, Inc.
GQL · Antisera, Fluorescent, Herpesvirus Hominis 1,2 · 129d
Cleared Jul 06, 1983
GLUCOSE OXIDASE/PEROXIDASE TEST
K831411 · King Diagnostics, Inc.
CGA · Glucose Oxidase, Glucose · 65d
Cleared Jun 30, 1983
OXY-SWAB
K831673 · Austin Biological Laboratories
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 38d
Cleared Jun 30, 1983
RIM-CAMP TEST
K831674 · Austin Biological Laboratories
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 38d
Cleared Jun 22, 1983
MICRO TRAK HSV1 & 2 CULTURE CONFIRMATION
K830953 · Syva Co.
GQL · Antisera, Fluorescent, Herpesvirus Hominis 1,2 · 89d
Cleared Jun 22, 1983
RIM BETA LACTAMASE TEST
K831654 · Austin Biological Laboratories
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 30d
Cleared Jun 22, 1983
SPECTRUM-10
K831672 · Austin Biological Laboratories
JSS · Kit, Identification, Enterobacteriaceae · 30d
Cleared Jun 17, 1983
SPECTRUM-10
K831655 · Austin Biological Laboratories
JSZ · Kit, Identification, Pseudomonas · 25d
Cleared Jun 16, 1983
RAPID IDENTIFI-METHOD NEISSERIA KIT
K830968 · Austin Biological Laboratories
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 80d

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