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 02, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN-TAZOBACTAM 0.5/4-128/4 UG/ML
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
41d
Cleared
Nov 22, 2004
STATUS FIRST STREP A
GTY
Antigens, All Groups, Streptococcus Spp.
249d
Cleared
Nov 22, 2004
BBLCHROMAGAR MRSA
JSO
Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
41d
Cleared
Nov 19, 2004
WEST NILE DETECT IGM ELISA
NOP
Elisa, Antibody, West Nile Virus
136d
Cleared
Nov 19, 2004
ETEST FOR GEMIFLOXACIN
JWY
Manual Antimicrobial Susceptibility Test Systems
78d
Cleared
Nov 15, 2004
XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B
LLH
Reagents, Clostridium Difficile Toxin
118d
Cleared
Oct 22, 2004
IDI-MRSA ASSAY
NQX
System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
52d
Cleared
Oct 20, 2004
WEST NILE VIRUS IGG INDIRECT ELISA
NOP
Elisa, Antibody, West Nile Virus
177d
Cleared
Oct 07, 2004
PASCO MIC AND MIC/ID PANELS
JWY
Manual Antimicrobial Susceptibility Test Systems
38d
Cleared
Sep 27, 2004
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
33d
Cleared
Sep 14, 2004
VITEK 2 GRAM NEGATIVE ERTAPENEM
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
53d
Cleared
Sep 14, 2004
DAPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
JTN
Susceptibility Test Discs, Antimicrobial
35d
Cleared
Aug 20, 2004
IMMUNOCARD TOXINS A & B, MODEL 712050
LLH
Reagents, Clostridium Difficile Toxin
123d
Cleared
Aug 13, 2004
IMMUNOCARD STAT! RSV MODEL #750630
GQG
Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus
73d
Cleared
Aug 12, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERCILLIN (GN) 0.5-128 UG/ML
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
59d
Cleared
Aug 10, 2004
BINAXNOW INFLUENZA A & B TEST
PSZ
Devices Detecting Influenza A, B, And C Virus Antigens
110d
Cleared
Aug 10, 2004
WEST NILE VIRUS IGM CAPTURE ELISA, MODEL E-WNV02M
NOP
Elisa, Antibody, West Nile Virus
92d
Cleared
Aug 03, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAZIDIME - GRAM NEGATIVE
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
70d
Cleared
Aug 03, 2004
PASCO MIC AND MIC/ID PANELS
JWY
Manual Antimicrobial Susceptibility Test Systems
33d
Cleared
Jul 27, 2004
ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING
NGZ
Susceptibility Test Plate, Antifungal
146d
Cleared
Jul 27, 2004
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE AND SUSCEPTIBILITY TEST PANEL
JWY
Manual Antimicrobial Susceptibility Test Systems
49d
Cleared
Jul 22, 2004
MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELS
LRG
Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
80d
Cleared
Jul 22, 2004
SAS INFLUENZA B TEST
PSZ
Devices Detecting Influenza A, B, And C Virus Antigens
51d
Cleared
Jul 22, 2004
SAS INFLUENZA A TEST
PSZ
Devices Detecting Influenza A, B, And C Virus Antigens
51d
Cleared
Jul 15, 2004
POCONE INFRARED SPECTROPHOTOMETER
MSQ
Test, Urea (breath Or Blood)
73d
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