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
5934 Microbiology devices
3001–3025 of 5934
Cleared Feb 12, 1993
KALLESTAD RSV MICROPLATE EIA
K924289 · Bio-Rad Laboratories, Inc.
MCE · Respiratory Syncytial Virus - Elisa · 175d
Cleared Feb 03, 1993
BAC-T-SCREEN
K924218 · Biomerieux Vitek, Inc.
JXA · Kit, Screening, Urine · 167d
Cleared Feb 01, 1993
CLOSTRIDIUM DIFFICILE TOXIN/ANTITOXIN KIT
K923463 · Techlab, Inc.
LLH · Reagents, Clostridium Difficile Toxin · 202d
Cleared Jan 27, 1993
PREMIER C. DIFFICILE, MODIFICATION
K926442 · Meridian Diagnostics, Inc.
LLH · Reagents, Clostridium Difficile Toxin · 42d
Cleared Jan 26, 1993
IMMUNOCARD(TM) C. DIFFICILE
K924979 · Meridian Diagnostics, Inc.
LLH · Reagents, Clostridium Difficile Toxin · 117d
Cleared Jan 26, 1993
BBL PYR REAGENT DROPPERS
K926254 · Becton Dickinson Microbiology Systems
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 39d
Cleared Jan 26, 1993
BBL NITRATE A, B REAGENT DROPPERS
K926255 · Becton Dickinson Microbiology Systems
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 39d
Cleared Jan 26, 1993
BBL NINHYDRIN REAGENT DROPPERS
K926256 · Becton Dickinson Microbiology Systems
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 39d
Cleared Jan 15, 1993
CYTOQUANT COMBINED TRANSPORT MEDIA
K924053 · Proteins Intl., Inc.
LIO · Device, Specimen Collection · 156d
Cleared Jan 15, 1993
MICROSPORIDIUM CONTROL SLIDE
K924893 · Scientific Device Laboratory, Inc.
LJG · Quality Control Slides · 109d
Cleared Jan 15, 1993
CATION ADJUSTED MUELLER HINTON BROTH
K925644 · Pasco Laboratories, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 67d
Cleared Jan 15, 1993
EZ VIEW
K925693 · Difco Laboratories, Inc.
MDB · System, Blood Culturing · 64d
Cleared Jan 15, 1993
DRYSLIDE(TM) INDOLE
K925747 · Difco Laboratories, Inc.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 63d
Cleared Jan 11, 1993
EBV-VCA IGG ELISA TEST SYSTEM
K924091 · Zeus Scientific, Inc.
MCD · Antigen, Ebv, Capsid · 151d
Cleared Jan 06, 1993
RESP. PANEL 1 INDIRECT IMMUNOFLUORESCENCE ASSAY
K922801 · Light Diagnostics
GNY · Antisera, Fluorescent, Adenovirus 1-33 · 210d
Cleared Dec 29, 1992
BARTEL PRIMA SYSTEM INFLUENZA A ENZYME IMMUNOASSAY
K924006 · Baxter Healthcare Corp
GNX · Antigens, Cf (including Cf Control), Influenza Virus A, B, C · 141d
Cleared Dec 28, 1992
ORTHO HSV ANTIGEN ELISA TEST, MODIFICATION
K925208 · Ortho Diagnostic Systems, Inc.
LGC · Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific · 91d
Cleared Dec 15, 1992
BARTELS HERPES SIMPLEX VIRUS 2 IGM EIA
K922333 · Baxter Diagnostics, Inc.
LGC · Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific · 216d
Cleared Dec 15, 1992
BARTELS HERPES SIMPLEX VIRUS 1 IGM EIA
K922334 · Baxter Diagnostics, Inc.
LGC · Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific · 216d
Cleared Dec 11, 1992
DRIED GRAM-NEGATIVE AND POSITIVE MIC/COMBO PANELS
K922458 · Baxter Healthcare Corp
JWY · Manual Antimicrobial Susceptibility Test Systems · 199d
Cleared Dec 07, 1992
VIGIL II
K920845 · Beckman Instruments, Inc.
DCK · C-reactive Protein, Antigen, Antiserum, And Control · 286d
Cleared Dec 07, 1992
ACCUTEX ASO LATEX TEST
K924247 · J.S. Medical Assoc.
GTQ · Antistreptolysin - Titer/streptolysin O Reagent · 105d
Cleared Dec 03, 1992
ARBOVIRUS IGG IFA TEST
K913617 · Hillcrest Biologicals
GQC · Antisera, Cf, Equine Encephalitis Virus, Eee, Wee · 478d
Cleared Dec 03, 1992
ARBOVIRUS IGM IFA TEST
K913618 · Hillcrest Biologicals
GQC · Antisera, Cf, Equine Encephalitis Virus, Eee, Wee · 478d
Cleared Dec 03, 1992
API UNISCEPT MIC/TYPE 2 AND 3 AND MICRO MIC
K923684 · Analytical Products, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 133d

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All categories 5934 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 OCC Respiratory Virus Panel Nucleic Acid Assay System 75 LYR Helicobacter Pylori 75