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
4126–4150 of 5941
Cleared Sep 19, 1986
TOC (TWEEN 80 - OXGALL-CAFFEIC ACID) AGAR
K863523 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JSH · Culture Media, Non-selective And Differential · 9d
Cleared Sep 19, 1986
REGAN-LOWE CHARCOAL AGAR
K863524 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JSJ · Culture Media, Selective And Non-differential · 9d
Cleared Sep 19, 1986
DERMATOPHYTE TEST MEDIUM, SLANTS AND MYCOFLASKS
K863525 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JSI · Culture Media, Selective And Differential · 9d
Cleared Sep 19, 1986
YEP (YEAST EXTRACT PHOSPHATE) AGAR
K863526 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JSJ · Culture Media, Selective And Non-differential · 9d
Cleared Sep 19, 1986
CARY-BLAIR TRANSPORT MEDIUM
K863527 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JSM · Culture Media, Non-propagating Transport · 9d
Cleared Sep 17, 1986
RESISTANT 6 MIC PANEL
K862978 · Pasco Laboratories, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 41d
Cleared Sep 17, 1986
MODIFICATION OF CDT(TM) CLOSTRIDIUM TEST
K863485 · Marion Laboratories, Inc.
LLH · Reagents, Clostridium Difficile Toxin · 8d
Cleared Sep 16, 1986
ABBOTT RSV EIA
K862429 · Abbott Laboratories
GQG · Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus · 82d
Cleared Sep 16, 1986
RESPIRASTICK ENZYME IMMUNOASSAY TEST
K862475 · Orion Diagnostica, Inc.
GTY · Antigens, All Groups, Streptococcus Spp. · 78d
Cleared Sep 16, 1986
ABBOTT TESTPACK (TM) ACUTE HEP A CONTROL KIT
K863099 · Abbott Laboratories
JJK · Oncometer, Plasma, For Clinical Use · 34d
Cleared Sep 15, 1986
BACTEC 13A MEDIUM (7H13)
K863191 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JSJ · Culture Media, Selective And Non-differential · 27d
Cleared Sep 15, 1986
NEIS NZY
K863216 · Carr-Scarborough Microbiologicals, Inc.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 26d
Cleared Sep 11, 1986
TOXONOSTIKA IGM MICROELISA SYSTEM
K862196 · Organon Teknika Corp.
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 94d
Cleared Sep 11, 1986
GRAM NEGATIVE FLUORESCENT IDENTIFICATION PANEL
K862642 · American Micro Scan
LQM · Gram Negative Identification Panel · 62d
Cleared Sep 08, 1986
ORGANON TEKNIKA TOXONOSTIKA IGG MICROELISA SYSTEM
K862189 · Organon Teknika Corp.
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 91d
Cleared Sep 03, 1986
MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM
K862630 · Medical Diagnostic Technologies, Inc.
GSA · Antisera, All Mycoplasma Spp. · 55d
Cleared Sep 03, 1986
CDC ANAEROBIC AGAR W/SHEEP BLOOD, KANA-&VANCOMYCIN
K863289 · Gibco Laboratories Life Technologies, Inc.
JSJ · Culture Media, Selective And Non-differential · 9d
Cleared Aug 27, 1986
ANAEROBE RAPID CHROMOGENIC ID PANEL
K862332 · American Micro Scan
JSP · Kit, Anaerobic Identification · 69d
Cleared Aug 27, 1986
AGAR REDUCTION IN FORMULA FOR PDC 110 & 310 MEDIA
K863164 · Precision Dynamics Corp.
JSM · Culture Media, Non-propagating Transport · 9d
Cleared Aug 26, 1986
VISIBLE-CHLAMYDIA(TM) TEST SYSTEM
K862638 · Isolab, Inc.
LJC · Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) · 47d
Cleared Aug 21, 1986
CELLMATICS RSV DETECTION SYSTEM
K862321 · Difco Laboratories, Inc.
LKT · Respiratory Syncytial Virus, Antigen, Antibody, Ifa · 64d
Cleared Aug 19, 1986
MODIFIED IDEIA CHLAMYDIA TEST
K861966 · Boots-Celltech Diagnostics, Inc.
LJC · Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) · 91d
Cleared Aug 19, 1986
DIFCO CHLAMYDIA DIRECT DETECTION SYSTEM
K862320 · Difco Laboratories, Inc.
LJP · Antiserum, Fluorescent, Chlamydia Trachomatis · 62d
Cleared Aug 12, 1986
SEROIDEN STREPTO KIT 'EIKEN'
K861098 · Syn-Kit, Inc.
GTZ · Antisera, All Groups, Streptococcus Spp. · 141d
Cleared Aug 08, 1986
FIAX TEST KIT FOR MYCOPLASMA PNEUMONIAE-G ANTIBODY
K861716 · Whittaker Bioproducts, Inc.
GRZ · Antisera, Fluorescent, All, Mycoplasma Spp. · 94d

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