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
5940 Microbiology devices
3926–3950 of 5940
Cleared Aug 07, 1987
IAFP BRAIN HEART INFUSION BROTH
K872667 · I.A.F. Production, Inc.
JSG · Culture Media, Non-selective And Non-differential · 31d
Cleared Aug 07, 1987
IAFP T.S.A. W/10% SHEEP BLOOD
K872668 · I.A.F. Production, Inc.
JSG · Culture Media, Non-selective And Non-differential · 31d
Cleared Aug 07, 1987
IAFP T.S.A. W/5% SHEEP BLOOD
K872671 · I.A.F. Production, Inc.
KZI · Culture Media, Enriched · 31d
Cleared Aug 07, 1987
IAFP B.H.I. AGAR
K872677 · I.A.F. Production, Inc.
JSG · Culture Media, Non-selective And Non-differential · 31d
Cleared Aug 07, 1987
IAFP THIOGLYCOLLATE W/O INDICATOR W/HEMIN&VITA. K1
K872678 · I.A.F. Production, Inc.
KZI · Culture Media, Enriched · 31d
Cleared Aug 07, 1987
IAFP T.S.A. (TRYPTIC SOY AGAR)
K872679 · I.A.F. Production, Inc.
JSG · Culture Media, Non-selective And Non-differential · 31d
Cleared Aug 06, 1987
BBL(R) GASPAK CO2 POUCH(TM)
K872782 · Bd Becton Dickinson Vacutainer Systems Preanalytic
KZJ · Device, Gas Generating · 23d
Cleared Aug 06, 1987
MICROTRAK CHLAMYDIA TRACHO. TEST - METHANOL FIXAT.
K872903 · Syva Co.
LJP · Antiserum, Fluorescent, Chlamydia Trachomatis · 10d
Cleared Aug 06, 1987
AMPICIILLIN SULBACTAM 20MCG SENSITIVITY DISKS
K872938 · Difco Laboratories, Inc.
JTN · Susceptibility Test Discs, Antimicrobial · 10d
Cleared Jul 31, 1987
CAPTIA(R) TOXO-M: AN ENZYME IMMUNOASSAY
K871746 · Mercia Diagnostics , Ltd.
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 87d
Cleared Jul 31, 1987
RESPIRATORY SYNCYTIAL VIRUS CONTROL SLIDE
K872082 · Medical Diagnostic Technologies, Inc.
LKT · Respiratory Syncytial Virus, Antigen, Antibody, Ifa · 63d
Cleared Jul 30, 1987
RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIUM TUBER.
K871795 · Gen-Probe, Inc.
LQF · Dna-reagents, Mycobacterium Spp. · 84d
Cleared Jul 30, 1987
TOXOPLASMA GONDII IGG ELISA
K871905 · Electro-Nucleonics Laboratories, Inc.
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 76d
Cleared Jul 27, 1987
AMPICILLIN/SULBACTAM 20 MCG SENSI-DISC
K872783 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JTN · Susceptibility Test Discs, Antimicrobial · 13d
Cleared Jul 20, 1987
ENZYGNOST ANTI-CMV IGG TEST
K863488 · Behring Diagnostics, Inc.
GQI · Antiserum, Cf, Cytomegalovirus · 314d
Cleared Jul 09, 1987
DULBECCO'S MODIFIED EAGLE'S MEDIUM (DME)
K872465 · J R Scientific
KIT · Media And Components, Synthetic Cell And Tissue Culture · 16d
Cleared Jul 09, 1987
PRECISION CULTURE C.A.T.S. COLLECT/TRANS HSV I/II
K872507 · Precision Dynamics Corp.
JSM · Culture Media, Non-propagating Transport · 15d
Cleared Jul 01, 1987
MODIFIED TOXOPLASMA GONDII IGG EIA TEST KIT
K872252 · Labsystems, Inc.
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 20d
Cleared Jun 25, 1987
EBV-CHECK(TM) TEST KIT (IGG)
K871373 · Diagnostic Technology, Inc.
GNP · Antiserum, Cf, Epstein-barr Virus · 79d
Cleared Jun 24, 1987
MACCONKEY W/SORBITOL
K872188 · Remel Co.
JSI · Culture Media, Selective And Differential · 16d
Cleared Jun 22, 1987
FLETCHER'S MEDIUM & FLETCHER'S MEDIUM W/5-FU
K872193 · Bd Becton Dickinson Vacutainer Systems Preanalytic
KZI · Culture Media, Enriched · 14d
Cleared Jun 17, 1987
PATHO DX LATEX AGGLUTINATION STREP GROUPING KIT
K871831 · Diagnostic Products Corp.
GTZ · Antisera, All Groups, Streptococcus Spp. · 37d
Cleared Jun 15, 1987
SENSIR SYSTEM
K870719 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JWY · Manual Antimicrobial Susceptibility Test Systems · 115d
Cleared Jun 15, 1987
MODIFIED (DIRECTIONS FOR USE) FOR IDEIA(TM) TEST
K872056 · Boots-Celltech Diagnostics, Inc.
LJC · Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) · 18d
Cleared Jun 15, 1987
MCBRIDE MEDIUM CM 819
K872135 · Oxoid U.S.A., Inc.
JSJ · Culture Media, Selective And Non-differential · 12d

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All categories 5940 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