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
4551–4575 of 5941
Cleared Feb 27, 1985
HBSS-HANKS' BALANCED SALT SOLUTION
K850524 · Mediatech, Inc.
KIT · Media And Components, Synthetic Cell And Tissue Culture · 19d
Cleared Feb 27, 1985
DPBS-DULBECCO'S PHOSPHATE BUFFERED SALINE
K850525 · Mediatech, Inc.
KIT · Media And Components, Synthetic Cell And Tissue Culture · 19d
Cleared Feb 27, 1985
EBSS W/O CA & MG-EARLE'S BALANCED SALT SOLUTION
K850526 · Mediatech, Inc.
KIT · Media And Components, Synthetic Cell And Tissue Culture · 19d
Cleared Feb 25, 1985
TRYPSIN 10X - 1:250 IN HBSS W/O CA & MG
K844878 · Hazleton Research Products, Inc.
KIP · Formulations, Balanced Salt Solutions · 70d
Cleared Feb 25, 1985
IDENTIFICATION STICKS OXIDASE
K844887 · Oxoid U.S.A., Inc.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 70d
Cleared Feb 25, 1985
AZIDE AGAR W/5% SHEEP BLOOD
K844934 · American Laboratory Supply, Inc.
JSI · Culture Media, Selective And Differential · 68d
Cleared Feb 19, 1985
MODIFICATION OF ABL MIC-10 PRECEPT SYS
K843612 · Austin Biological Laboratories
LTD · Paraquat Assay · 159d
Cleared Feb 14, 1985
PHARMACIA B2-MICRO EIA
K844469 · Pharmacia, Inc.
JZG · System, Test, Beta-2-microglobulin Immunological · 87d
Cleared Feb 06, 1985
IMAGEN CHLAMYDIA TEST
K844683 · Boots-Celltech Diagnostics, Inc.
IWP · Radiographic Protective Glove · 68d
Cleared Jan 30, 1985
BIO-STAT III PLATE WASHER
K844552 · Whittaker Bioproducts, Inc.
JTC · Device, Microtiter Diluting/dispensing · 70d
Cleared Jan 30, 1985
TITERTEK DULUTER/DISPENSER 78-640-00
K844568 · Flow Laboratories, Inc.
JTC · Device, Microtiter Diluting/dispensing · 68d
Cleared Jan 30, 1985
CAMPYPAK PLUS W/PALLADIUM CATALYST DISPOS. HYDROGE
K844571 · Bd Becton Dickinson Vacutainer Systems Preanalytic
KZJ · Device, Gas Generating · 68d
Cleared Jan 30, 1985
PDC 104 & PDC 304 STYLE CULTURE COLLECTION & TRANS
K844634 · Precision Dynamics Corp.
JSM · Culture Media, Non-propagating Transport · 64d
Cleared Jan 29, 1985
CULTURESET HSV ISOLATION & ID SYS
K842216 · Ortho Diagnostic Systems, Inc.
GQL · Antisera, Fluorescent, Herpesvirus Hominis 1,2 · 239d
Cleared Jan 25, 1985
DIRECTIGEN NEISSENA MENNINGITIDIS GROUP B TEST
K844407 · Bd Becton Dickinson Vacutainer Systems Preanalytic
GTJ · Antisera, All Groups, N. Meningitidis · 73d
Cleared Jan 23, 1985
HEMOCLIP X-20 AUTOMATIC HEMOCLIP LIGATING APPLIER
K844836 · Edward Weck, Inc.
GWD · Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp · 42d
Cleared Jan 22, 1985
TITERTEK MICROPLATE WASHER 120
K844500 · Flow Laboratories, Inc.
JTC · Device, Microtiter Diluting/dispensing · 63d
Cleared Jan 18, 1985
MICROTRAK HSV 1 & 2 DIRECT SPECIMAN
K841190 · Syva Co.
GQL · Antisera, Fluorescent, Herpesvirus Hominis 1,2 · 303d
Cleared Jan 16, 1985
CYSTINE TRYPTIC AGAR W/DEXTROSE
K844542 · bioMerieux, Inc.
JSF · Culture Media, Single Biochemical Test · 56d
Cleared Jan 16, 1985
CYSTINE TRYPTIC AGAR W/LACTOSE
K844543 · bioMerieux, Inc.
JSF · Culture Media, Single Biochemical Test · 56d
Cleared Jan 16, 1985
CYSTINE TRYPTIC AGAR W/MALTOSE
K844544 · bioMerieux, Inc.
JSF · Culture Media, Single Biochemical Test · 56d
Cleared Jan 16, 1985
CYSTINE TRYPTIC AGAR W/MANNITOL
K844545 · bioMerieux, Inc.
JSF · Culture Media, Single Biochemical Test · 56d
Cleared Jan 16, 1985
CYSTINE TRYPTIC AGAR W/SUCROSE
K844546 · bioMerieux, Inc.
JSF · Culture Media, Single Biochemical Test · 56d
Cleared Jan 16, 1985
TRYPTIC SOY BROTH W/6.5%SODIUM CHLORIDE
K844547 · bioMerieux, Inc.
JSD · Culture Media, Selective Broth · 56d
Cleared Jan 16, 1985
UREA AGAR
K844548 · bioMerieux, Inc.
JSH · Culture Media, Non-selective And Differential · 56d

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