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
5931 Microbiology devices
2301–2325 of 5931
Cleared Nov 17, 1997
BACT/ALERT CULTURE BOTTLES
K973305 · Organon Teknika Corp.
MDB · System, Blood Culturing · 75d
Cleared Nov 14, 1997
PASCO MIC AND MIC/ID PANELS
K973317 · Pasco Laboratories, Inc.
LTT · Panels, Test, Susceptibility, Antimicrobial · 72d
Cleared Nov 13, 1997
SERODIA TP-PA
K971502 · Scimedx Tekfile Services
GMT · Antigens, Ha, Treponema Pallidum · 203d
Cleared Nov 05, 1997
SERAQUEST VZV IGG
K972295 · Quest Intl., Inc.
LFY · Enzyme Linked Immunoabsorbent Assay, Varicella-zoster · 139d
Cleared Nov 05, 1997
PASCO MIC AND MIC/ID PANELS
K973695 · Pasco Laboratories, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 40d
Cleared Nov 04, 1997
MUMPS IGG ELISA TESTY
K971857 · Gull Laboratories, Inc.
LJY · Enzyme Linked Immunoabsorbent Assay, Mumps Virus · 168d
Cleared Oct 29, 1997
THE MERETEK UBT BREATH TEST FOR H.PYLORI
K972352 · Meretek Diagnostics, Inc.
MSQ · Test, Urea (breath Or Blood) · 127d
Cleared Oct 22, 1997
TOXOPLASMA IGM ASSAY FOR THE BAYER IMMUNO1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
K971989 · Bayer Corp.
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 146d
Cleared Oct 21, 1997
SERAQUEST TOXOPLASMA IGM
K971672 · Quest Intl., Inc.
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 167d
Cleared Oct 16, 1997
QUIX RAPID E. COLI O157 STRIP TEST
K972156 · Guardian Scientific, Corp.
GMZ · Antigens, All Types, Escherichia Coli · 129d
Cleared Oct 10, 1997
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K972799 · Dade Microscan, Inc.
LTT · Panels, Test, Susceptibility, Antimicrobial · 74d
Cleared Oct 10, 1997
LOMEFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K973488 · Oxoid , Ltd.
JTN · Susceptibility Test Discs, Antimicrobial · 25d
Cleared Oct 10, 1997
LORACARBEF ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K973489 · Oxoid , Ltd.
JTN · Susceptibility Test Discs, Antimicrobial · 25d
Cleared Oct 08, 1997
SNAP SWAB CULTURE COLLECTION AND TRANSPORT SYSTEM
K972726 · Medical Packaging Corp.
JSM · Culture Media, Non-propagating Transport · 79d
Cleared Oct 08, 1997
ACCURUN 140 RUBELLA IGG POSITIVE CONTROL
K972986 · Boston Biomedica, Inc.
MJX · Kit, Serological, Positive Control · 58d
Cleared Oct 06, 1997
CEFPODOXIME ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K973487 · Oxoid , Ltd.
JTN · Susceptibility Test Discs, Antimicrobial · 21d
Cleared Oct 03, 1997
VIDAS ROTAVIRUS (RTV) ASSAY
K972895 · Biomerieux Vitek, Inc.
LIQ · Enzyme Linked Immunoabsorbent Assay, Rotavirus · 59d
Cleared Sep 25, 1997
FRESH CELLS VERO
K973209 · Diagnostic Hybrids, Inc.
KIR · Cells, Animal And Human, Cultured · 29d
Cleared Sep 25, 1997
FRESH CELLS NCI H292
K973210 · Diagnostic Hybrids, Inc.
KIR · Cells, Animal And Human, Cultured · 29d
Cleared Sep 25, 1997
FRESH CELLS MV1LU
K973211 · Diagnostic Hybrids, Inc.
KIR · Cells, Animal And Human, Cultured · 29d
Cleared Sep 25, 1997
FRESH CELLS WI-38
K973212 · Diagnostic Hybrids, Inc.
KIR · Cells, Animal And Human, Cultured · 29d
Cleared Sep 25, 1997
FRESH CELLS LLC-MK2
K973213 · Diagnostic Hybrids, Inc.
KIR · Cells, Animal And Human, Cultured · 29d
Cleared Sep 25, 1997
FRESH CELLS HFF
K973214 · Diagnostic Hybrids, Inc.
KIR · Cells, Animal And Human, Cultured · 29d
Cleared Sep 17, 1997
RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTURE
K971508 · Bio-Whittaker, Inc., A Cambrex Co.
KIR · Cells, Animal And Human, Cultured · 145d
Cleared Sep 10, 1997
VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES
K971494 · Zymetx, Inc.
GNX · Antigens, Cf (including Cf Control), Influenza Virus A, B, C · 139d

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All categories 5931 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 98 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