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
2326–2350 of 5931
Cleared Sep 08, 1997
STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUS
K972030 · Oxoid , Ltd.
JWX · Kit, Screening, Staphylococcus Aureus · 98d
Cleared Sep 08, 1997
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K972524 · Dade Intl., Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 63d
Cleared Sep 08, 1997
MICROSCAN DRIED GRAM POSITIVE MIC/COMBO PANELS LEVOFLOXACIN
K972688 · Dade Microscan, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 63d
Cleared Aug 29, 1997
FRESHCELLS
K972414 · Diagnostic Hybrids, Inc.
KIR · Cells, Animal And Human, Cultured · 63d
Cleared Aug 28, 1997
REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCIN
K972359 · Remel, L.P.
JSO · Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar · 64d
Cleared Aug 25, 1997
VISTA ANTIGEN SALMONELLA O GROUP B
K972386 · Lee Laboratories, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 60d
Cleared Aug 25, 1997
VISTA ANTIGEN SALMONELLA O GROUP A
K972387 · Lee Laboratories, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 60d
Cleared Aug 25, 1997
VISTA ANTIGEN SALMONELLA O GROUP C
K972388 · Lee Laboratories, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 60d
Cleared Aug 25, 1997
VISTA ANTIGEN SALMONELLA H D
K972389 · Lee Laboratories, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 60d
Cleared Aug 25, 1997
VISTA ANTIGEN SALMONELLA H C
K972390 · Lee Laboratories, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 60d
Cleared Aug 25, 1997
VISTA ANTIGEN SALMONELLA H B
K972391 · Lee Laboratories, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 60d
Cleared Aug 25, 1997
VISTA ANTIGEN SALMONELLA H A
K972392 · Lee Laboratories, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 60d
Cleared Aug 25, 1997
VISTA ANTIGEN BRUCELLA ABORTUS
K972394 · Lee Laboratories, Inc.
GSO · Antigens (febrile), Agglutination, Brucella Spp. · 60d
Cleared Aug 25, 1997
VISTA ANTIGEN SALMONELLA O GROUP D
K972395 · Lee Laboratories, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 60d
Cleared Aug 25, 1997
VISTA ANTIGEN BRUCELLA MELITENSIS
K972396 · Lee Laboratories, Inc.
GSO · Antigens (febrile), Agglutination, Brucella Spp. · 60d
Cleared Aug 22, 1997
ACCURUN 146 CMV IGM POSITIVE CONTROL
K972884 · Boston Biomedica, Inc.
LKQ · Antibody Igm,if, Cytomegalovirus Virus · 17d
Cleared Aug 20, 1997
MYCOPLASMA IGM ELISA TEST SYSTEM
K971503 · Zeus Scientific, Inc.
LJZ · Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. · 118d
Cleared Aug 20, 1997
IMMUNOCARD STAT! ROTAVIRUS
K971585 · Meridian Diagnostics, Inc.
LIQ · Enzyme Linked Immunoabsorbent Assay, Rotavirus · 111d
Cleared Aug 20, 1997
CLARITHROMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K971638 · Oxoid , Ltd.
JTN · Susceptibility Test Discs, Antimicrobial · 110d
Cleared Aug 20, 1997
COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL
K972448 · Copan Italia Spa
JSL · Culture Media, Anaerobic Transport · 51d
Cleared Aug 20, 1997
COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOAL
K972449 · Copan Italia Spa
JSL · Culture Media, Anaerobic Transport · 51d
Cleared Aug 20, 1997
PASCO MIC AND MIC/ID PANELS
K972567 · Pasco Laboratories, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 50d
Cleared Aug 15, 1997
PASCO MIC AND MIC/ID PANELS
K971951 · Pasco Laboratories, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 79d
Cleared Aug 13, 1997
TICARCILLIN/CLAVULANIC ACID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K971632 · Oxoid , Ltd.
JTN · Susceptibility Test Discs, Antimicrobial · 103d
Cleared Aug 13, 1997
ABBOTT STREP A CONTROLS
K972182 · Abbott Diagnostics
MJZ · Kit, Direct Antigen, Positive Control · 76d

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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