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
2701–2725 of 7095
Cleared Jun 18, 1996
SAS SALMONELLA H G,M,Q ANTISERMU
K961956 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 29d
Cleared Jun 18, 1996
SAS SALMONELLA H Z4, Z32 ANTISERUM
K961957 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 29d
Cleared Jun 18, 1996
SAS SALMONELLA H Z4 COMPLEX ANTISERUM
K961958 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 29d
Cleared Jun 18, 1996
SAS SALMONELLA H Z4, Z24 ANTISERUM
K961960 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 29d
Cleared Jun 18, 1996
SAS SALMONELLA H F,G,T ANTISERUM
K961961 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 29d
Cleared Jun 18, 1996
SAS SALMONELLA O GROUP V FACTOR 44 ANTISERUM
K961962 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 29d
Cleared Jun 18, 1996
SAS SALMONELLA O GROUP W FACTOR 45 ANTISERUM
K961963 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 29d
Cleared Jun 18, 1996
SAS SALMONELLA O GROUP H FACTORS 14,24,25 ANTISERUM
K961964 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 29d
Cleared Jun 18, 1996
SAS SALMONELLA O GROUP X FACTOR 47 ANTISERUM
K961966 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 29d
Cleared Jun 18, 1996
SAS SALMONELLA O POLY B ANTISERUM
K961967 · Sa Scientific, Inc.
GRM · Antisera, All Groups, Salmonella Spp. · 29d
Cleared Jun 17, 1996
IMMULITE CMV IGG
K950672 · Diagnostic Products Corp.
LFZ · Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus · 490d
Cleared Jun 17, 1996
VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAINFLUENZA VIRUSES
K950838 · Zymetx, Inc.
GNT · Antigens, Ha (including Ha Control), Influenza Virus A, B, C · 479d
Cleared Jun 17, 1996
SERAQUEST TOXOPLASMA IGG
K960092 · Quest Intl., Inc.
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 158d
Cleared Jun 17, 1996
SYPHILIS IGG HUMAN SERUM CONTROLS
K960493 · Pyramid Biological Corp.
LIP · Enzyme Linked Immunoabsorption Assay, Treponema Pallidum · 137d
Cleared Jun 17, 1996
COLISCREEN
K961191 · Hardy Diagnostics
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 83d
Cleared Jun 07, 1996
MARDX LYME DISEASE (IGM) MARBLOT STRIP TEST SYSTEM
K951709 · Mardx Diagnostics, Inc.
LSR · Reagent, Borrelia Serological Reagent · 421d
Cleared Jun 07, 1996
CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY
K951821 · Light Diagnostics
LIN · Antisera, Conjugated Fluorescent, Cytomegalovirus · 414d
Cleared Jun 07, 1996
LMD CRYPTOSPORIDIUM ANTIGEN DETECTION
K955345 · Lmd Laboratories
MHJ · Cryptosporidium Spp. · 199d
Cleared Jun 07, 1996
FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT DIAGNOSTICS)ANDCONTROLS FOR FLEXPACK HP (ABBOTT DIAGNOSTICS)
K960183 · Smithkline Diagnostics, Inc.
LYR · Helicobacter Pylori · 143d
Cleared Jun 05, 1996
MARDX LYME DISEASE (IGG) MARBLOT STRIP TEST SYSTEM
K950829 · Mardx Diagnostics, Inc.
LSR · Reagent, Borrelia Serological Reagent · 468d
Cleared May 31, 1996
SAS SHIGELLA SONNEI FORM II ANTISERUM
K961537 · Sa Scientific, Inc.
GNB · Antisera, All Types, Shigella Spp. · 39d
Cleared May 30, 1996
IMX SELECT CHLAMYDIA
K936054 · Abbott Laboratories
LJC · Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) · 891d
Cleared May 30, 1996
DIRECTIGEN MENINGITIS COMBO TEST
K952791 · Bd Becton Dickinson Vacutainer Systems Preanalytic
GTJ · Antisera, All Groups, N. Meningitidis · 346d
Cleared May 30, 1996
H292 CELL CULTURE
K960909 · Neogenex
KIR · Cells, Animal And Human, Cultured · 86d
Cleared May 30, 1996
MICROSCAN RAPID GRAM-NEGATIVE INDENTIFICATION TYPE 3 PANEL
K961042 · Dade Microscan, Inc.
LRH · Instrument For Auto Reader Of Overnight Microorganism Identification System · 77d

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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