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
7095
Total
7032
Cleared
150d
Avg (2y)
1976
Since
7095 Microbiology devices
Cleared
Jan 10, 2011
VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST +(RVNAT+)
OCC
Respiratory Virus Panel Nucleic Acid Assay System
70d
Cleared
Jan 06, 2011
CLEARVIEW EXACT II INFLUENZA A & B TEST
PSZ
Devices Detecting Influenza A, B, And C Virus Antigens
28d
Cleared
Dec 21, 2010
OSOM C. DIFFICILE TOXIN A/B TEST
LLH
Reagents, Clostridium Difficile Toxin
134d
Cleared
Dec 17, 2010
HARDYDISK AST CEFTAROLINE, 30 UG MODEL Z939
JTN
Susceptibility Test Discs, Antimicrobial
15d
Cleared
Dec 16, 2010
GNR TRAFFIC LIGHT PNA FISH
JSS
Kit, Identification, Enterobacteriaceae
195d
Cleared
Dec 03, 2010
BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEM
LFX
Enzyme Linked Immunoabsorbent Assay, Rubella
466d
Cleared
Dec 03, 2010
PRODESSE PROADENO
OCC
Respiratory Virus Panel Nucleic Acid Assay System
59d
Cleared
Nov 24, 2010
SIMPLEXA FLU A/B & RSV
OCC
Respiratory Virus Panel Nucleic Acid Assay System
114d
Cleared
Nov 17, 2010
ETEST TOBRAMYCIN 0.016-256 UG/ML AND 0.064-1024 UG/ML
JWY
Manual Antimicrobial Susceptibility Test Systems
62d
Cleared
Nov 10, 2010
BIOSIGN FLU A+B
PSZ
Devices Detecting Influenza A, B, And C Virus Antigens
693d
Cleared
Oct 29, 2010
MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS
JSO
Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
241d
Cleared
Oct 29, 2010
3M INTEGRATED CYCLER (110V) & (220V)
OOI
Real Time Nucleic Acid Amplification System
74d
Cleared
Oct 21, 2010
VITEK 2 GRAM POSITIVE DOXCYCLINE
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
386d
Cleared
Oct 08, 2010
REMEL SPECTRA MRSA
JSO
Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
428d
Cleared
Oct 05, 2010
ANTI-HAV
LOL
Hepatitis A Test (antibody And Igm Antibody)
187d
Cleared
Oct 01, 2010
ATHENA MULTI-LYTE TREPONEMA PALLIDUM IGG PLUS TEST SYSTEM
LIP
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
290d
Cleared
Sep 29, 2010
CRIT-LINE ANEMIA MANAGEMENT SOFTWARE
MSQ
Test, Urea (breath Or Blood)
289d
Cleared
Sep 28, 2010
VITEK 2 YEAST CASPOFUNGIN
NGZ
Susceptibility Test Plate, Antifungal
116d
Cleared
Sep 24, 2010
QUICKVUE RSV 10
GQG
Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus
77d
Cleared
Sep 10, 2010
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES
LRG
Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
113d
Cleared
Aug 25, 2010
ETEST MOXIFLOXACIN 0.002-32 UG/ML
JWY
Manual Antimicrobial Susceptibility Test Systems
278d
Cleared
Aug 20, 2010
BBL CHROMAGAR MRSA II
JSO
Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
345d
Cleared
Jul 28, 2010
XPERT MRSA/SA BC (BLOOD CULTURE) ASSAY MODEL GXMRSA/SA-BC-10
NQX
System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
22d
Cleared
Jul 23, 2010
PROFAST+ ASSAY
OQW
2009 H1n1 Influenza Virus (swine Origin), Nucleic Acid Or Antigen, Detection And Identification
22d
Cleared
Jul 22, 2010
AUDIT MICROCV PROCALCITONIN LINEARITY
MJX
Kit, Serological, Positive Control
62d
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