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

7095
Total
7032
Cleared
150d
Avg (2y)
1976
Since
7095 Microbiology devices
2776–2800 of 7095
Cleared Mar 22, 1996
BINAX STREP A TEST
K960712 · Binax, Inc.
GTZ · Antisera, All Groups, Streptococcus Spp. · 30d
Cleared Mar 20, 1996
VARICELLA-ZOSTER VIRUS DIRECT IMMUNOFLUORESCENCE ASSAY
K951799 · Light Diagnostics
GQX · Antiserum, Cf, Varicella-zoster · 336d
Cleared Mar 19, 1996
CALCOFLUOR WHITE STAIN KIT
K960090 · Remel Co.
JTS · Stains, Microbiologic · 68d
Cleared Mar 19, 1996
BACTIDROP CALCOFLUOR WHITE
K960095 · Remel Co.
JTS · Stains, Microbiologic · 68d
Cleared Mar 14, 1996
VARICELISA, MODIFICATION
K943843 · Biowhittaker Molecular Applications, Inc.
LFY · Enzyme Linked Immunoabsorbent Assay, Varicella-zoster · 595d
Cleared Mar 12, 1996
VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI)
K952095 · Biomerieux Vitek, Inc.
LQL · Gram Positive Identification Panel · 313d
Cleared Mar 12, 1996
SAS SALMONELLA O GROUP Y FACTOR 48 ANTISERUM
K960129 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 61d
Cleared Mar 12, 1996
SAS SALMONELLA O GROUP Z FACTOR 50 ANTISERUM
K960130 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 61d
Cleared Mar 12, 1996
SAS SALMONELLA 0 GROUP E FACTORS 1,3,10,15,19,34 ANTISERUM
K960147 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 61d
Cleared Mar 12, 1996
SAS SALMONELLA 0 GROUP M FACTOR 28 ANTISERUM
K960160 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 61d
Cleared Mar 12, 1996
SAS SALMONELLA O GROUP R FACTOR 40 ANTISERUM
K960461 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 42d
Cleared Mar 11, 1996
SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES
K960220 · Sensititre , Ltd.
JWY · Manual Antimicrobial Susceptibility Test Systems · 55d
Cleared Mar 06, 1996
SAS SALMONELLA O FACTOR 18 ANTISERUM &/OR SAS SALMONELLA O GROUP K FACTOR 18 ANTISERUM
K960123 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 55d
Cleared Mar 06, 1996
SAS SALMONELLA 0 FACTOR 10 ANTISERUM AND/OR SAS SALMONELLA 0 GROUP E1 FACTOR 10 ANTISERUM
K960124 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 55d
Cleared Mar 06, 1996
SAS SALMONELLA O FACTOR 4 ANTISERUM &/OR SAS SALMONELLA O GROUP B FACTOR 4,5 ANTISERUM
K960125 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 55d
Cleared Mar 06, 1996
SAS SALMONELLA O FACTOR 19 ANTISERUM &/OR SAS SALMONELLA O GROUP E4 FACTOR 19 ANTISERUM
K960126 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 55d
Cleared Mar 06, 1996
SAS SALMONELLA O FACTOR 22 ANTISERUM &/OR SAS SALMONELLA O GROUP G1 FACTOR 22 ANTISERUM
K960127 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 55d
Cleared Mar 06, 1996
SAS SALMONELLA H U ANTISERUM
K960132 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 50d
Cleared Mar 06, 1996
SAS SALMONELLA 0 FACTOR 9 ANTISERUM AND/OR SAS SALMONELLA 0 GROUP D FACTOR 9 ANTISERUM
K960134 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 55d
Cleared Mar 06, 1996
SAS SALMONELLA H M ANTISERUM
K960135 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 50d
Cleared Mar 06, 1996
SAS SALMONELLA H P ANTISERUM
K960136 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 50d
Cleared Mar 06, 1996
SAS SALMONELLA H Z10 ANTISERUM
K960137 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 50d
Cleared Mar 06, 1996
SAS SALMONELLA 0 FACTOR 8 ANTISERUM AND/OR SAS SALMONELLA 0 GROUP C2 FACTOR 9 ANTISERUM
K960138 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 55d
Cleared Mar 06, 1996
SAS SALMONELLA 0 FACTOR ANTISERUM AND/OR SAS SALMONELLA 0 GROUP C1 FACTOR 7 ANTISERUM
K960140 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 55d
Cleared Mar 06, 1996
SAS SALMONELLA 0 FACTOR 23 ANTISERUM AND/OR SAS SLAMONELLA 0 GROUP G2 FACTOR 23 ANTISERUM
K960142 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 55d

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All categories 7095 JWY Manual Antimicrobial Susceptibility Test Systems 441 JTN Susceptibility Test Discs, Antimicrobial 323 JSJ Culture Media, Selective And Non-differential 299 LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation 291 JSI Culture Media, Selective And Differential 267 JTO Discs, Strips And Reagents, Microorganism Differentiation 239 JSG Culture Media, Non-selective And Non-differential 198 JSH Culture Media, Non-selective And Differential 142 LSR Reagent, Borrelia Serological Reagent 112 JSM Culture Media, Non-propagating Transport 110 LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii 104 GTZ Antisera, All Groups, Streptococcus Spp. 99 LFX Enzyme Linked Immunoabsorbent Assay, Rubella 92 LYR Helicobacter Pylori 91 JSF Culture Media, Single Biochemical Test 87