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
5943 Microbiology devices
5026–5050 of 5943
Cleared Jun 15, 1983
AUTOANTIBODY SCREEN TEST SYSTEM
K831358 · Zeus Scientific, Inc.
DBM · Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control · 50d
Cleared Jun 12, 1983
URINE SCREENING KIT
K830824 · Syn-Kit, Inc.
CEN · Dye-indicator, Ph (urinary, Non-quantitative) · 89d
Cleared Jun 08, 1983
DATA-ZYME ALKALINE PHOSPHATASE PROCED
K831360 · Data Medical Associates, Inc.
CJE · Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes · 43d
Cleared Jun 08, 1983
LEGIONELLA CYE AGAR BASE & BCYE SUPPL
K831469 · Oxoid U.S.A., Inc.
JSK · Supplement, Culture Media · 33d
Cleared Jun 08, 1983
LA-STAPH IDENTIFICATION SYSTEM
K831918 · Immuno-Mycologics, Inc.
JWX · Kit, Screening, Staphylococcus Aureus
Cleared May 27, 1983
DIRECTIGEN NEISSERIA MENINGITIDIS
K830646 · Bd Becton Dickinson Vacutainer Systems Preanalytic
· 87d
Cleared May 25, 1983
BERA SH 221 BRIAN STEM AUDIOMETER
K830173 · Jedmed Instrument Co.
GNJ · Antigens, Ha, Echovirus 1-34 · 127d
Cleared May 25, 1983
AZLIN AZLOCILIN SODIUM-DIAG. REAGENT
K830758 · Miles Laboratories, Inc.
JTT · Susceptibility Test Powders, Antimicrobial · 76d
Cleared May 18, 1983
API 20GP
K830525 · Analytical Products, Inc.
JSE · Culture Media, Multiple Biochemical Test · 90d
Cleared May 18, 1983
MODIFIED NEW YORK MEDIUM
K831359 · Gibco Laboratories Life Technologies, Inc.
JTY · Culture Media, For Isolation Of Pathogenic Neisseria · 22d
Cleared May 16, 1983
STREPTOCOCUS ID PLATE
K831349 · Granite Diagnostics, Inc.
JST · Kit, Fastidious Organisms · 21d
Cleared May 13, 1983
CLOSTRIDIUM DIFFICILE SELECTIVE SUPPLE
K831219 · Gibco Laboratories Life Technologies, Inc.
JSK · Supplement, Culture Media · 28d
Cleared May 13, 1983
TILL-U-TEST G.C. GONOCOCUS SLIDE
K831268 · Pasco Laboratories, Inc.
JTY · Culture Media, For Isolation Of Pathogenic Neisseria · 25d
Cleared May 13, 1983
CLOSTRIDIUM DIFFICLE MEDIA
K831279 · Gibco Laboratories Life Technologies, Inc.
JSJ · Culture Media, Selective And Non-differential · 14d
Cleared May 09, 1983
BIOCULT - GC CULTURE-PADDLES
K831124 · Orion Diagnostica, Inc.
JTY · Culture Media, For Isolation Of Pathogenic Neisseria · 34d
Cleared May 09, 1983
CEFAXOLIN 30 MCG SENSI-DISC
K831153 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JTN · Susceptibility Test Discs, Antimicrobial · 31d
Cleared May 09, 1983
CEFAZOLIN 30MCG. ANTIMICROBIAL SUSCEP
K831179 · General Diagnostics
JTN · Susceptibility Test Discs, Antimicrobial · 28d
Cleared May 09, 1983
RAPID NFT
K831186 · Dms Laboratories
JSN · Culture Media, Propagating Transport · 27d
Cleared May 09, 1983
TRP
K831187 · Dms Laboratories
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 27d
Cleared May 09, 1983
CLOSTRIDIUM DIFFICILE MEDIA
K831220 · Gibco Laboratories Life Technologies, Inc.
JSJ · Culture Media, Selective And Non-differential · 24d
Cleared May 05, 1983
LA-HISTO ANTIBODY SYSTEM #HL 1001
K830837 · Immuno-Mycologics, Inc.
GMJ · Antigens, Histoplasma Capsulatum, All · 50d
Cleared May 05, 1983
API ANAIDENT
K831032 · Analytical Products, Inc.
JSP · Kit, Anaerobic Identification · 36d
Cleared May 04, 1983
ANAEROBE MIC/ID TEMPLATE, & TAXONOMY
K830964 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JSP · Kit, Anaerobic Identification · 37d
Cleared Apr 28, 1983
I/A KIT
K831159 · Staar Surgical Co.
JSM · Culture Media, Non-propagating Transport · 17d
Cleared Apr 27, 1983
PHADEBACT STREP F TEST
K830445 · Pharmacia, Inc.
GTZ · Antisera, All Groups, Streptococcus Spp. · 76d

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All categories 5943 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