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
5301–5325 of 5943
Cleared Dec 31, 1981
MYCO-IMMUNE TM HISTOPLASMIN LATEX AGGL
K813359 · American Scientific Products
GMJ · Antigens, Histoplasma Capsulatum, All · 31d
Cleared Dec 31, 1981
CELLULOSE ACETATE-CITRATE AGAR HEMOGLO
K813395 · Helena Laboratories
JBD · System, Analysis, Electrophoretic Hemoglobin · 27d
Cleared Dec 31, 1981
PIPERACILLIN 100 MCG. SENSI DISC
K813441 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JTN · Susceptibility Test Discs, Antimicrobial · 21d
Cleared Dec 31, 1981
METRONIDAZOLE DIAGNOSTIC DISCS
K813509 · Oxoid U.S.A., Inc.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 16d
Cleared Dec 30, 1981
BBL DIRECTIGEN TEST KIT
K812808 · Bd Becton Dickinson Vacutainer Systems Preanalytic
GTY · Antigens, All Groups, Streptococcus Spp. · 85d
Cleared Dec 29, 1981
METRONIDAZOLE 80MCG. SENSI-DISC
K813387 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JTN · Susceptibility Test Discs, Antimicrobial · 27d
Cleared Dec 29, 1981
CEFINASE TM DISCS
K813442 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 19d
Cleared Dec 22, 1981
BI-LEVEL ACETAMINOPHEN-SALICYLATE CNRL
K813349 · Stanbio Laboratory
DIF · Drug Mixture Control Materials · 25d
Cleared Dec 17, 1981
MINOCYCLINE 30MCG ANTIMICROBIAL SUS. DSK
K812994 · General Diagnostics
JTN · Susceptibility Test Discs, Antimicrobial · 52d
Cleared Dec 17, 1981
MS-2 BACTERIAL IDENTIFICATION SYS
K813031 · Abbott Laboratories
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 50d
Cleared Dec 08, 1981
UROPAPER EIKEN UHAG
K811816 · Syn-Kit, Inc.
JIL · Method, Enzymatic, Glucose (urinary, Non-quantitative) · 165d
Cleared Dec 03, 1981
COOKED MEAT MEDIUM
K813232 · Oxoid U.S.A., Inc.
JSG · Culture Media, Non-selective And Non-differential · 16d
Cleared Nov 24, 1981
DULBECCO MINIMUM ESSENTIAL MED NO GLUTAM
K812885 · Dutchland Laboratories, Inc.
KIT · Media And Components, Synthetic Cell And Tissue Culture · 41d
Cleared Nov 10, 1981
BACTEC RESIN CULTURE MED. 16A
K812315 · Bd Becton Dickinson Vacutainer Systems Preanalytic
MDB · System, Blood Culturing · 85d
Cleared Nov 10, 1981
MOXALACTOM 30MCG ANTIMICROBIAL SUS. DISK
K812993 · General Diagnostics
JTN · Susceptibility Test Discs, Antimicrobial · 15d
Cleared Nov 06, 1981
VDRL CARBON ANTIGEN
K812894 · Oxoid U.S.A., Inc.
GMQ · Antigens, Nontreponemal, All · 22d
Cleared Nov 06, 1981
BCYE MEDIUM
K812911 · Gibco Laboratories Life Technologies, Inc.
JSE · Culture Media, Multiple Biochemical Test · 18d
Cleared Nov 06, 1981
MEZLOCILLIN 75MCG ANTIMICROB. SUSCEPT. D
K812916 · General Diagnostics
JTN · Susceptibility Test Discs, Antimicrobial · 18d
Cleared Nov 06, 1981
FIAX RHEUMATOID FACTOR TEST KIT
K812968 · Intl. Diagnostic Technology
DHR · System, Test, Rheumatoid Factor · 15d
Cleared Nov 06, 1981
RA LATEX TEST
K812972 · Oxoid U.S.A., Inc.
DHR · System, Test, Rheumatoid Factor · 14d
Cleared Oct 28, 1981
MOXALACTAM 30 MCG. SENSITIVITY DISCS
K812228 · Difco Laboratories, Inc.
JTN · Susceptibility Test Discs, Antimicrobial · 79d
Cleared Oct 26, 1981
RHEUMATEX
K812882 · Armkel, LLC
DHR · System, Test, Rheumatoid Factor · 12d
Cleared Oct 23, 1981
SEPTI-CHEK COLUMBIA BROTH BLOOD CULTURE
K812730 · Hoffmann-La Roche, Inc.
JSG · Culture Media, Non-selective And Non-differential · 25d
Cleared Oct 23, 1981
TRIMETHOPRIM 5MCG. ANTIMICROBIAL DISK
K812783 · General Diagnostics
JTN · Susceptibility Test Discs, Antimicrobial · 18d
Cleared Oct 23, 1981
TITERTEK AUTODROP
K812818 · Flow Laboratories, Inc.
JTC · Device, Microtiter Diluting/dispensing · 16d

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