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
4676–4700 of 5943
Cleared Aug 23, 1984
AUGMENTIN 30 MCG SENSI DISC
K842253 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JTN · Susceptibility Test Discs, Antimicrobial · 77d
Cleared Aug 20, 1984
MINIMUM ESSENTIAL MED W/L-GLUTAMINE
K842776 · Sigma Chemical Co.
KIT · Media And Components, Synthetic Cell And Tissue Culture · 35d
Cleared Aug 20, 1984
BIOTIS CDC MODIFIED MCCLUNG-TOABE EGG
K843065 · Otisville Biotech, Inc.
KZI · Culture Media, Enriched · 14d
Cleared Aug 20, 1984
BIOTIS CIN AGAR PLATES
K843066 · Otisville Biotech, Inc.
JSI · Culture Media, Selective And Differential · 14d
Cleared Aug 17, 1984
MIN. ESSENTIAL MED. W/L-GLUTAMINE, RIB
K842775 · Sigma Chemical Co.
KIT · Media And Components, Synthetic Cell And Tissue Culture · 32d
Cleared Aug 12, 1984
ORTHO RESPIRATORY SYNCYTIAL VIRUS-
K841527 · Ortho Diagnostic Systems, Inc.
LKT · Respiratory Syncytial Virus, Antigen, Antibody, Ifa · 122d
Cleared Aug 02, 1984
MICROTRAK CHLAMYDIA TRACHOMATIS DIRECT
K842623 · Syva Co.
LJP · Antiserum, Fluorescent, Chlamydia Trachomatis · 28d
Cleared Jul 27, 1984
SICKLE CELL STAT A/S HETEROZYGOUS-ERYTH
K842440 · Anco Medical Reagents & Assoc.
JPK · Mixture, Hematology Quality Control · 36d
Cleared Jul 27, 1984
B.E.C. GROWTH CHEK MICROBIAL SUSPENSIONS
K842579 · Biological & Environmental Control Laboratories
JTR · Kit, Quality Control For Culture Media · 24d
Cleared Jul 26, 1984
CEFONICID 30 MCG SENSITIVITY DISCS
K842292 · Difco Laboratories, Inc.
JTN · Susceptibility Test Discs, Antimicrobial · 45d
Cleared Jul 26, 1984
RAPID PLASMA REAGIN CARD TEST
K842541 · Clinical Sciences, Inc.
GMQ · Antigens, Nontreponemal, All · 24d
Cleared Jul 20, 1984
CHLAMYDIAE IMMUNOPEROXIDASE TEST KIT
K842151 · Bartels Immunodiagnostic Supplies, Inc.
LKH · Antisera, Immunoperoxidase, Chlamydia Spp. · 51d
Cleared Jul 20, 1984
CEFONICID 30 MCG SENSI-DISC
K842252 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JTN · Susceptibility Test Discs, Antimicrobial · 43d
Cleared Jul 20, 1984
BECTEC NR-660 BACTERIAL DETECT SYS
K842279 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JTA · Monitor, Microbial Growth · 42d
Cleared Jul 20, 1984
GENERAL DIAG. CEFONICID 30MCG ANTIMIC
K842307 · General Diagnostics
JTN · Susceptibility Test Discs, Antimicrobial · 38d
Cleared Jul 20, 1984
GNC PLUS
K842587 · Vitek Systems, Inc.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 17d
Cleared Jul 06, 1984
BACTIGEN - N.MENNINIGITIDIS TEST
K841907 · Armkel, LLC
GTJ · Antisera, All Groups, N. Meningitidis · 59d
Cleared Jul 03, 1984
SPOTTEST LACTOPHENOL COTTON BLUE STAIN
K842086 · Difco Laboratories, Inc.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 40d
Cleared Jul 02, 1984
VENTRESCREEN STREP A TEST
K842239 · Ventrex Laboratories, Inc.
GWC · Antisera, All Types, Streptococcus Pneumoniae · 27d
Cleared Jul 02, 1984
PATHO DX LATEX AGGLUTINATION STREP A
K842383 · Diagnostic Products Corp.
GTZ · Antisera, All Groups, Streptococcus Spp. · 14d
Cleared Jul 02, 1984
BIOTIS N.Y.C. CARBOHYDRATE FERMENTA-
K842400 · Otisville Biotech, Inc.
· 13d
Cleared Jul 02, 1984
BIOTIS LD-PRESUMPTO QUADRANT PLATE
K842424 · Otisville Biotech, Inc.
JSE · Culture Media, Multiple Biochemical Test · 12d
Cleared Jul 02, 1984
RIM STREP KIT
K842451 · Austin Biological Laboratories
JSE · Culture Media, Multiple Biochemical Test · 10d
Cleared Jun 27, 1984
IMR-90-DIPLOID-HUMAN FETAL LUNG CELL
K841998 · Bartels Immunodiagnostic Supplies, Inc.
KIR · Cells, Animal And Human, Cultured · 42d
Cleared Jun 25, 1984
ORTHO VARICELLA-ZOSTER VIRUS IDENT.
K841526 · Ortho Diagnostic Systems, Inc.
GQX · Antiserum, Cf, Varicella-zoster · 74d

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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