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
2751–2775 of 7095
Cleared May 20, 1996
SAS SHIGELLA BOYDII TYPE 10 ANTISERUM
K961554 · Sa Scientific, Inc.
GNB · Antisera, All Types, Shigella Spp. · 28d
Cleared May 20, 1996
SAS SHIGELLA FLEXNERI TYPE 1 ANTISERUM
K961556 · Sa Scientific, Inc.
GNB · Antisera, All Types, Shigella Spp. · 28d
Cleared May 20, 1996
SAS SHIGELLA FLEXNERI TYPE 3 ANTISERUM
K961558 · Sa Scientific, Inc.
GNB · Antisera, All Types, Shigella Spp. · 28d
Cleared May 20, 1996
SAS SHIGELLA DYSENTERIAE TYPE 9 ANTISERUM
K961559 · Sa Scientific, Inc.
GNB · Antisera, All Types, Shigella Spp. · 28d
Cleared May 17, 1996
CYTOQUANT CHLAMYDIA TRANSPORT MEDIUM
K961755 · Proteins Intl., Inc.
JSN · Culture Media, Propagating Transport · 11d
Cleared May 17, 1996
CYTOQUANT VIRAL TRANSPORT MEDIUM
K961756 · Proteins Intl., Inc.
JSN · Culture Media, Propagating Transport · 11d
Cleared May 14, 1996
TOXOSTAT
K944867 · Bio-Whittaker, Inc., A Cambrex Co.
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 595d
Cleared May 14, 1996
ABBOTT AXSYM RUBELLA IGM ANTIBODY ASSAY
K954318 · Abbott Laboratories
LFX · Enzyme Linked Immunoabsorbent Assay, Rubella · 242d
Cleared May 06, 1996
LCX NEISSERIA GONORRHOEAE ASSAY
K935833 · Abbott Laboratories
LSL · Dna-reagents, Neisseria · 881d
Cleared May 03, 1996
IMMUNO DOT BORRELIA DOT BLOT G TEST
K953682 · Genbio
LSR · Reagent, Borrelia Serological Reagent · 270d
Cleared May 03, 1996
MMUNO DOT BORRELIA DOT BLOT M TEST
K953683 · Genbio
LSR · Reagent, Borrelia Serological Reagent · 270d
Cleared Apr 29, 1996
EBNA IGG EIA TEST SYSTEM
K951549 · Immunoprobe, Inc.
LLM · Test, Antigen, Nuclear, Epstein-barr Virus · 391d
Cleared Apr 26, 1996
CEFEPIME DISPANS-O-DISC (CEFEPLIME - 30MCG)
K961148 · Difco Laboratories, Inc.
JTW · System, Transport, Aerobic · 36d
Cleared Apr 18, 1996
IMMUNOCARD TOXIN A
K955859 · Meridian Diagnostics, Inc.
LLH · Reagents, Clostridium Difficile Toxin · 113d
Cleared Apr 18, 1996
M. CAT BUTYRATE DISK
K960996 · Hardy Diagnostics
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 37d
Cleared Apr 15, 1996
RUBELLA IGG ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC DEVICE
K951359 · Bayer Corp.
LFX · Enzyme Linked Immunoabsorbent Assay, Rubella · 385d
Cleared Apr 15, 1996
CARDS Q.S. STREP A
K955108 · Quidel Corp.
GTZ · Antisera, All Groups, Streptococcus Spp. · 159d
Cleared Apr 10, 1996
HAEMOPHILUS TEST MEDIUM (HTM)
K952595 · Clinical Standards Laboratories, Inc.
JSO · Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar · 309d
Cleared Apr 09, 1996
ACCESS RUBELLA IGG
K954687 · Bio-Rad Laboratories, Inc.
LFX · Enzyme Linked Immunoabsorbent Assay, Rubella · 181d
Cleared Apr 09, 1996
SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES
K960366 · Accumed Intl., Inc.
LTT · Panels, Test, Susceptibility, Antimicrobial · 75d
Cleared Apr 05, 1996
CEFEPIME, 30 MCG, SENSI-DISC
K961188 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JTN · Susceptibility Test Discs, Antimicrobial · 10d
Cleared Apr 04, 1996
MUELLER HINTON AGAR WITH 5% SHEEP BLOOD
K960420 · Becton Dickinson Microbiology Systems
JTZ · Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth · 66d
Cleared Apr 03, 1996
STARSWAB CULTURE COLLECTION AND TRANSPORT SYSTEM
K960997 · Starplex Scientific, Inc.
LIO · Device, Specimen Collection · 22d
Cleared Mar 27, 1996
SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES
K960235 · Accumed Intl., Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 70d
Cleared Mar 25, 1996
MUELLER HINTON AGAR WITH 2% NACI
K960313 · Remel, L.P.
JTZ · Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth · 63d

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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