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
2701–2725 of 5932
Cleared Feb 07, 1996
SAS SALMONELLA H 1,7 ANTISERUM
K955218 · Sa Scientific, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 85d
Cleared Feb 07, 1996
SAS SALMONELLA H FACTOR 7 ANTISERUM
K955219 · Sa Scientific, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 85d
Cleared Feb 07, 1996
SAS SALMONELLA H Z36 ANTISERUM
K955220 · Sa Scientific, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 85d
Cleared Feb 07, 1996
SAS SALMONELLA H Z38 ANTISERUM
K955221 · Sa Scientific, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 85d
Cleared Feb 06, 1996
QUICKVUE ONE-STEP HELICOBACTOR PYLORI TEST
K952517 · Quidel Corp.
LYR · Helicobacter Pylori · 251d
Cleared Feb 06, 1996
DRYSLIDE CARTARRHALIS
K954783 · Difco Laboratories, Inc.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 112d
Cleared Feb 02, 1996
SAS SALMONELLA H Z29 ANTISERUM
K955186 · Sa Scientific, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 80d
Cleared Feb 02, 1996
SAS SALMONELLA H Z4, Z23 ANTISERUM
K955187 · Sa Scientific, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 80d
Cleared Feb 02, 1996
SAS SALMONELLA H Z6 ANTISERUM
K955188 · Sa Scientific, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 80d
Cleared Feb 02, 1996
SAS SALMONELLA H Z ANTISERUM
K955189 · Sa Scientific, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 80d
Cleared Feb 02, 1996
SAS SALMONELLA H Y ANTISERUM
K955190 · Sa Scientific, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 80d
Cleared Feb 02, 1996
SAS SALMONELLA H X ANTISERUM
K955191 · Sa Scientific, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 80d
Cleared Feb 02, 1996
SAS SALMONELLA H T ANTISERUM
K955192 · Sa Scientific, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 80d
Cleared Feb 02, 1996
SAS SALMONELLA H S ANTISERUM
K955193 · Sa Scientific, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 80d
Cleared Feb 02, 1996
SAS SALMONELLA H R ANTISERUM
K955194 · Sa Scientific, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 80d
Cleared Feb 02, 1996
SAS SALMONELLA H POLY C ANTISERUM
K955198 · Sa Scientific, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 80d
Cleared Feb 02, 1996
SAS SALMONELLA H POLY B ANTISERUM
K955199 · Sa Scientific, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 80d
Cleared Feb 02, 1996
SAS SALMONELLA H POLY A ANTISERUM
K955200 · Sa Scientific, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 80d
Cleared Feb 02, 1996
SAS SALMONELLA H,M,T, ANTISERUM
K955201 · Sa Scientific, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 80d
Cleared Feb 02, 1996
SAS SALMONELLA H L,Z40 ANTISERUM
K955202 · Sa Scientific, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 80d
Cleared Feb 02, 1996
SAS SALMONELLA H L,Z13 ANTISERUM
K955203 · Sa Scientific, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 80d
Cleared Feb 02, 1996
SAS SALMONELLA H L,W ANTISERUM
K955204 · Sa Scientific, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 80d
Cleared Feb 02, 1996
SAS SALMONELLA H L,V ANTISERUM
K955205 · Sa Scientific, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 80d
Cleared Feb 02, 1996
SAS SALMONELLA H K ANTISERUM
K955206 · Sa Scientific, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 80d
Cleared Feb 02, 1996
SAS SALMONELLA H I ANTISERUM
K955207 · Sa Scientific, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 80d

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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