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
2726–2750 of 5932
Cleared Feb 02, 1996
SAS SALMONELLA H H ANTISERUM
K955208 · Sa Scientific, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 80d
Cleared Feb 02, 1996
SAS SALMONELLA H G,M ANTISERUM
K955209 · Sa Scientific, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 80d
Cleared Feb 02, 1996
SAS SALMONELLA H F,G, ANTISERUM
K955210 · Sa Scientific, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 80d
Cleared Jan 30, 1996
CMV BRITE ANTIGENEMIA TEST KIT
K951550 · Biotest Diagnostics Corp.
LIN · Antisera, Conjugated Fluorescent, Cytomegalovirus · 301d
Cleared Jan 30, 1996
DRYSIDE NEISSERIA
K954784 · Difco Laboratories, Inc.
LTS · Test Reagents, Neisseria Gonorrhoeae Biochemical · 105d
Cleared Jan 30, 1996
HM-CAP CONTROL PANEL
K954926 · E-Z-Em, Inc.
LYR · Helicobacter Pylori · 96d
Cleared Jan 26, 1996
ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC)
K952819 · Abbott Laboratories
GTZ · Antisera, All Groups, Streptococcus Spp. · 220d
Cleared Jan 17, 1996
COLORSLIDER RUBELLA
K952544 · Seradyn, Inc.
LQN · Latex Agglutination Assay, Rubella · 229d
Cleared Jan 11, 1996
IDEIA(TM) CHLAMYDIA BLOCKING REAGENTS, MODIFICATION
K940564 · Dako Diagnostics , Ltd.
LJC · Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) · 707d
Cleared Dec 26, 1995
ESP CULTURE SYSTEM - MYCO
K953129 · Difco Laboratories, Inc.
MDB · System, Blood Culturing · 173d
Cleared Dec 20, 1995
ACCESS TOXO IGG ASSAY ON THE ACCESS IMMUNOASSAY SYSTEM
K951495 · Bio-Rad Laboratories, Inc.
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 264d
Cleared Dec 20, 1995
LYFO(TM) DIFFERIENTAL DISK-PYR
K954812 · Microbiologics, Inc.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 62d
Cleared Dec 18, 1995
SERIM PYLORITEK TEST KIT
K953632 · Serim Research Corp.
LYR · Helicobacter Pylori · 151d
Cleared Dec 12, 1995
AMOXICILLIN/CLAVULANIC ACID 2/1
K954319 · Ab Biodisk
JWY · Manual Antimicrobial Susceptibility Test Systems · 90d
Cleared Dec 08, 1995
LCX CHLAMYDIA TRACHOMATIS ASSAY
K934622 · Abbott Laboratories
MKZ · Dna Probe, Nucleic Acid Amplification, Chlamydia · 802d
Cleared Nov 16, 1995
MID-STREAM COLLECTION SET-STERILE
K953929 · Trinity Laboratories, Inc.
LIO · Device, Specimen Collection · 87d
Cleared Nov 14, 1995
PREMIER EHEC
K953362 · Meridian Diagnostics, Inc.
GNA · Antisera, All Types, Escherichia Coli · 120d
Cleared Oct 26, 1995
SAS SALMONELLA O GROUP A ANTIGEN
K953841 · Sa Scientific, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 71d
Cleared Oct 26, 1995
SAS SALMONELLA H C ANTIGEN
K953842 · Sa Scientific, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 71d
Cleared Oct 26, 1995
SAS SALMONELLA O GROUP F ANTIGEN
K953843 · Sa Scientific, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 71d
Cleared Oct 26, 1995
SAS SALMONELLA VI ANTIGEN
K953844 · Sa Scientific, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 71d
Cleared Oct 26, 1995
SAS SALMONELLA O GROUP C ANTIGEN
K953846 · Sa Scientific, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 71d
Cleared Oct 26, 1995
SAS SALMONELLA O GROUP B ANTIGEN
K953848 · Sa Scientific, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 71d
Cleared Oct 20, 1995
DIRECTIGEN 1-2-3 GROUP A STREP TEST
K951542 · Bd Becton Dickinson Vacutainer Systems Preanalytic
GTZ · Antisera, All Groups, Streptococcus Spp. · 200d
Cleared Oct 20, 1995
OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENT
K953437 · Olympus America, Inc.
GTQ · Antistreptolysin - Titer/streptolysin O Reagent · 91d

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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