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
2801–2825 of 7095
Cleared Mar 06, 1996
SAS SALMONELLA 0 FACTOR 27 ANTISERUM
K960145 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 55d
Cleared Mar 06, 1996
SAS SALMONELLA 0 GROUP F FACTOR 11 ANTISERUM
K960149 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 55d
Cleared Mar 06, 1996
SAS SALMONELLA 0 GROUP J FACTOR 17 ANTISERUM
K960150 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 55d
Cleared Mar 06, 1996
SAS SALMONELLA 0 FACTOR 12 ANTISERUM
K960152 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 55d
Cleared Mar 06, 1996
SAS SALOMNELLA 0 GROUP L FACTOR 21 ANTISERUM
K960153 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 55d
Cleared Mar 06, 1996
SAS SALMONELLA 0 GROUP N FACTOR 30 ANTISERUM
K960161 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 55d
Cleared Mar 06, 1996
SAS SALMONELLA 0 GROUP 0 FACTOR 35 ANTISERUM
K960162 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 55d
Cleared Mar 06, 1996
SAS SALMONELLA 0 FACTOR FACTOR 5 ANTISERUM
K960163 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 55d
Cleared Mar 06, 1996
SAS SALMONELLA O GROUP T FACTOR 42 ANTISERUM
K960458 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 36d
Cleared Mar 06, 1996
SAS SALMONELLA O GROUP S FACTOR 41 ANTISERUM
K960459 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 36d
Cleared Mar 06, 1996
SAS SALMONELLA O FACTOR 46 ANTISERUM
K960460 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 36d
Cleared Mar 06, 1996
SAS SALMONELLA O GROUP Q FACTOR 39 ANTISERUM
K960462 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 36d
Cleared Mar 06, 1996
SAS SALMONELLA O GROUP U FACTOR 43 ANTISERUM
K960463 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 36d
Cleared Mar 06, 1996
SAS SALMONELLA O GROUP P FACTOR 38 ANTISERUM
K960465 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 36d
Cleared Mar 04, 1996
SAS SALMONELLA H G ANTISERUM
K960131 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 48d
Cleared Mar 04, 1996
SAS SALMONELLA H F ANTISERUM
K960133 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 48d
Cleared Mar 04, 1996
SAS SALMONELLA H Z28 ANTISERUM
K960331 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 40d
Cleared Mar 04, 1996
SAS SALMONELLA H G,P,U ANTISERUM
K960333 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 40d
Cleared Mar 04, 1996
SAS SALMONELLA H POLY A-Z ANTISERUM
K960335 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 40d
Cleared Mar 04, 1996
SAS SALMONELLA H Z23 ANTISERUM
K960603 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 20d
Cleared Mar 04, 1996
SAS SALMONELLA H Z32 ANTISERUM
K960609 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 20d
Cleared Mar 04, 1996
SAS SALMONELLA H Z15 ANTISERUM
K960610 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 20d
Cleared Feb 29, 1996
GIBSON ID-M. CAT.
K955826 · Gibson Laboratories, Inc.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 65d
Cleared Feb 23, 1996
IMMULITE TOXOPLASMA GONDII IGG
K950671 · Diagnostic Products Corp.
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 375d
Cleared Feb 23, 1996
SERAQUEST CMV IGG
K954191 · Quest Intl., Inc.
LFZ · Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus · 170d

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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