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
5928 Microbiology devices
Cleared
Dec 14, 2005
QUICKVUE INFLUENZA A + B TEST
PSZ
Devices Detecting Influenza A, B, And C Virus Antigens
34d
Cleared
Dec 06, 2005
INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC
GTY
Antigens, All Groups, Streptococcus Spp.
169d
Cleared
Dec 05, 2005
ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MMRV IGG TEST SYSTEM.
LFY
Enzyme Linked Immunoabsorbent Assay, Varicella-zoster
182d
Cleared
Dec 01, 2005
VITEK 2 GRAM POSITIVE TELITHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
17d
Cleared
Nov 30, 2005
BINAXNOW INFLUENZA A & B TEST
PSZ
Devices Detecting Influenza A, B, And C Virus Antigens
23d
Cleared
Nov 28, 2005
BD VIPER SYSTEM
LSL
Dna-reagents, Neisseria
80d
Cleared
Nov 22, 2005
RPS ADENO DETECTOR
GOD
Antigens, Cf (including Cf Control), Adenovirus 1-33
112d
Cleared
Nov 18, 2005
JBAIDS ANTHRAC DETECTION SYSTEM
NHT
Assay, Nucleic Acid Amplification, Bacillus Anthracis
144d
Cleared
Nov 17, 2005
GIARDIA/CRYPTOSPORIDIUM CHEK
MHJ
Cryptosporidium Spp.
127d
Cleared
Nov 17, 2005
TIGECYCLINE 15UG BBL SENSI-DISC
JTN
Susceptibility Test Discs, Antimicrobial
37d
Cleared
Nov 14, 2005
TELITHROMYCIN 15UG BBL SENSI-DISC
JTN
Susceptibility Test Discs, Antimicrobial
33d
Cleared
Nov 07, 2005
VITEK GRAM POSITIVE SUSCEPTIBILITY DAPTOMYCIN
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
42d
Cleared
Nov 04, 2005
CRYPTOSPORIDIUM II
MHJ
Cryptosporidium Spp.
16d
Cleared
Oct 26, 2005
SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
58d
Cleared
Oct 13, 2005
ETEST TIGECYCLINE GRAM POSITIVE AND GRAM NEGATIVE AEROBIC BACTERIA, STREPTOCOCCUS SPP. AND ANAEROBIC BACTERIA
JWY
Manual Antimicrobial Susceptibility Test Systems
45d
Cleared
Oct 05, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFUROXIME (STREP) 0.125 - 4UG/ML
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
47d
Cleared
Oct 03, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -CIPROFLOXACIN GN
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
45d
Cleared
Sep 30, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TOBRAMYCIN (GP) 0.5-16UG/ML
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
43d
Cleared
Sep 29, 2005
VITEK 2 GRAM NEGATIVE TIGECYCLINE
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
36d
Cleared
Sep 21, 2005
SENSITIRE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS
JWY
Manual Antimicrobial Susceptibility Test Systems
50d
Cleared
Sep 12, 2005
BD PROBE TEC URINE PRESERVATIVE TRANSPORT
LSL
Dna-reagents, Neisseria
27d
Cleared
Aug 16, 2005
GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRACIS
NVQ
Bacteriophage And Controls, B. Anthracis Lysis
46d
Cleared
Aug 16, 2005
VITEK 2 GRAM POSITIVE ERTAPENEM FOR STREPTOCOCCUS PNEUMONIAE
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
40d
Cleared
Aug 11, 2005
VIRAMED BIOTECH BORRELIA B31 IGG VIRABLOT
LSR
Reagent, Borrelia Serological Reagent
107d
Cleared
Aug 11, 2005
BIRAMED BIOTECH BORRELIA B31 IGM VIRABLOT
LSR
Reagent, Borrelia Serological Reagent
104d
Looking for a specific microbiology device? Search by device name, K-number or manufacturer.
Search all Microbiology 510(k) devices