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
5932 Microbiology devices
2676–2700 of 5932
Cleared Feb 16, 1996
GC BASE W/ 1% GCHI
K954986 · Remel, L.P.
JTY · Culture Media, For Isolation Of Pathogenic Neisseria · 108d
Cleared Feb 16, 1996
A549 CELL CULTURE
K955921 · Viratest Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 64d
Cleared Feb 15, 1996
EBNA ENZYME IMMUNOASSAY KIT
K951822 · Granbio, Inc.
LLM · Test, Antigen, Nuclear, Epstein-barr Virus · 301d
Cleared Feb 14, 1996
ROTA-DAN RAPID ROTAVIRUS EIA KIT
K951208 · Eldan Technologies, Ltd.
LIQ · Enzyme Linked Immunoabsorbent Assay, Rotavirus · 334d
Cleared Feb 13, 1996
SAS SPICER-EDWARDS 1 COMPLEX
K955222 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 91d
Cleared Feb 13, 1996
SAS SPICER-EDWARDS 1 ANTISERUM
K955223 · Sa Scientific, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 91d
Cleared Feb 13, 1996
SAS SPICER-EDWARDS 2 ANTISERUM
K955224 · Sa Scientific, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 91d
Cleared Feb 13, 1996
SAS SPICER-EDWARDS 3 ANTISERUM
K955225 · Sa Scientific, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 91d
Cleared Feb 13, 1996
SAS SPICER-EDWARDS 4 ANTISERUM
K955226 · Sa Scientific, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 91d
Cleared Feb 13, 1996
SAS SPICER-EDWARDS EN COMPLEX ANTISERUM
K955227 · Sa Scientific, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 91d
Cleared Feb 13, 1996
SAS SPICER-EDWARDS L COMPLEX
K955228 · Sa Scientific, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 91d
Cleared Feb 09, 1996
HM-CAP EIA TEST (MODIFICATION)
K955085 · Schiff & Co.
LYR · Helicobacter Pylori · 106d
Cleared Feb 09, 1996
PROSPECT GIARDIA/CRYPTOSPORIDIUM MICROPLATE ASSAY
K955157 · Alexon Biomedical, Inc.
MHI · Giardia Spp. · 88d
Cleared Feb 08, 1996
BACTEC PEDS PLUS CLUTURE VIALS
K954924 · Becton Dickinson Diagnostic Instrument Systems
MDB · System, Blood Culturing · 105d
Cleared Feb 07, 1996
MYCOPLASMA SLURRY AND MYCOPLASMA CROWNTITRE IFA TEST SYSTEM
K946373 · Zeus Scientific, Inc.
GRZ · Antisera, Fluorescent, All, Mycoplasma Spp. · 518d
Cleared Feb 07, 1996
SAL SALMONELLA H Q ANTISERUM
K955195 · Sa Scientific, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 85d
Cleared Feb 07, 1996
SAS SALMONELLA H POLY E ANTISERUM
K955196 · Sa Scientific, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 85d
Cleared Feb 07, 1996
SAS SALMONELLA H POLY D ANTISERUM
K955197 · Sa Scientific, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 85d
Cleared Feb 07, 1996
SAS SALMONELLA H FACTOR 6 ANTISERUM
K955211 · Sa Scientific, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 85d
Cleared Feb 07, 1996
SAS SALMONELLA H FACTOR 5 ANTISERUM
K955212 · Sa Scientific, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 85d
Cleared Feb 07, 1996
SAS SALMONELLA H E,N,Z15 ANTISERUM
K955213 · Sa Scientific, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 85d
Cleared Feb 07, 1996
SAS SALMONELLA E,N,X ANTISERUM
K955214 · Sa Scientific, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 85d
Cleared Feb 07, 1996
SAS SALMONELLA H E COMPLEX ANTISERUM
K955215 · Sa Scientific, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 85d
Cleared Feb 07, 1996
SAS SALMONELLA H A ANTISERUM
K955216 · Sa Scientific, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 85d
Cleared Feb 07, 1996
SAS SALMONELLA H 1,2 ANTISERUM
K955217 · Sa Scientific, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 85d

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All categories 5932 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