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
150d
Avg (2y)
1976
Since
5945 Microbiology devices
5676–5700 of 5945
Cleared Nov 16, 1979
3M MICROBIAL PROFILE SYSTEM GRAM
K791789 · 3M Company
JSS · Kit, Identification, Enterobacteriaceae · 63d
Cleared Nov 16, 1979
FIAX TEST KIT FOR ANTI-CYTOMEGALORIRUS
K791948 · Intl. Diagnostic Technology
GQH · Antigen, Cf (including Cf Control), Cytomegalovirus · 46d
Cleared Nov 16, 1979
FISHER DIAGNOSTICS ANAEROBIC BLOOD CULT
K792056 · Fisher Scientific Co., LLC
JSC · Culture Media, General Nutrient Broth · 32d
Cleared Nov 13, 1979
BACTO-HATTS
K791897 · Difco Laboratories, Inc.
GMT · Antigens, Ha, Treponema Pallidum · 49d
Cleared Nov 13, 1979
AMS ENTEROBACTERIACEASE CARE
K791932 · Vitek Systems, Inc.
JSS · Kit, Identification, Enterobacteriaceae · 47d
Cleared Oct 30, 1979
PHENOL RED AGAR
K791939 · Isle Media and Sterile Products, Inc.
JSH · Culture Media, Non-selective And Differential · 29d
Cleared Oct 30, 1979
UREA AGAR
K791940 · Isle Media and Sterile Products, Inc.
JSI · Culture Media, Selective And Differential · 29d
Cleared Oct 30, 1979
PHENOL RED BROTH
K791941 · Isle Media and Sterile Products, Inc.
JSH · Culture Media, Non-selective And Differential · 29d
Cleared Oct 30, 1979
BILE ESCULIN AZIDE AGAR
K791942 · Isle Media and Sterile Products, Inc.
JSI · Culture Media, Selective And Differential · 29d
Cleared Oct 30, 1979
NUTRIENT AGAR
K791943 · Isle Media and Sterile Products, Inc.
JSG · Culture Media, Non-selective And Non-differential · 29d
Cleared Oct 30, 1979
NITRATE AGAR
K791944 · Isle Media and Sterile Products, Inc.
JSH · Culture Media, Non-selective And Differential · 29d
Cleared Oct 30, 1979
NITRATE BROTH
K791945 · Isle Media and Sterile Products, Inc.
JSF · Culture Media, Single Biochemical Test · 29d
Cleared Oct 30, 1979
OF BASAL MEDIUM
K791946 · Isle Media and Sterile Products, Inc.
JSH · Culture Media, Non-selective And Differential · 29d
Cleared Oct 30, 1979
PDC 304 DOUBLE SWAB CULTURE COLLECTION
K791953 · Precision Dynamics Corp.
JTW · System, Transport, Aerobic · 29d
Cleared Oct 17, 1979
CULTURE AND SENSITIVITY KIT
K791413 · Biomedia, Inc.
JTZ · Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth · 79d
Cleared Oct 17, 1979
DTM (DERMATOPHYTE TEST MEDIUM) AGAR
K791414 · Biomedia, Inc.
JSI · Culture Media, Selective And Differential · 79d
Cleared Oct 17, 1979
IMPROVED GRAM STAIN REAGENTS
K791711 · Carr-Scarborough Microbiologicals, Inc.
HYI · Iodine, Grams · 50d
Cleared Oct 17, 1979
BIO-BAG ENVIRONMENTAL CHAMBER (A & B)
K791724 · Marion Laboratories, Inc.
JTX · Transport Systems, Anaerobic · 48d
Cleared Oct 17, 1979
PDC 104 SINGLE SWAB CULTURE COLLECTION
K791924 · Precision Dynamics Corp.
JTW · System, Transport, Aerobic · 20d
Cleared Oct 11, 1979
CDC ANAEROBIC BLOOD AGAR PHENETHYLAL
K791697 · Gibco Laboratories Life Technologies, Inc.
JSJ · Culture Media, Selective And Non-differential · 44d
Cleared Oct 04, 1979
SALMONELLA SHIGELLA AGAR PLATE
K791786 · American Laboratory Supply, Inc.
JSI · Culture Media, Selective And Differential · 23d
Cleared Oct 04, 1979
MUELLER HINTON CHOCOLATE
K791815 · Isle Media and Sterile Products, Inc.
JTZ · Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth · 20d
Cleared Oct 01, 1979
SABOURAUD AGAR MODIFIED
K791670 · Isle Media and Sterile Products, Inc.
JSJ · Culture Media, Selective And Non-differential · 34d
Cleared Oct 01, 1979
DNASE TEST AGAR
K791671 · Isle Media and Sterile Products, Inc.
JSH · Culture Media, Non-selective And Differential · 34d
Cleared Oct 01, 1979
CDC ANAEROBIC SHEEP BLOOD AGAR (BA)
K791698 · Gibco Laboratories Life Technologies, Inc.
JSG · Culture Media, Non-selective And Non-differential · 34d

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All categories 5945 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 99 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