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
May 03, 2011
PREMIER C. DIFFICILE GDH
MCB
Antigen, C. Difficile
61d
Cleared
Apr 27, 2011
SENSITITRE AIM (TM)
LIE
Reagent/device, Inoculum Calibration
83d
Cleared
Apr 27, 2011
FILMARRAY RP PANEL
OCC
Respiratory Virus Panel Nucleic Acid Assay System
40d
Cleared
Apr 26, 2011
ZEUS ELISA HSV GC-I IGG TEST SYSTEM
MXJ
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
160d
Cleared
Apr 21, 2011
XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM, GENEXPERT SYSTEM SOFTWARE VERISIONS 2.1 AND 4.0
OQW
2009 H1n1 Influenza Virus (swine Origin), Nucleic Acid Or Antigen, Detection And Identification
119d
Not Cleared
Apr 19, 2011
APTIMA TRICHOMONAS VAGINALIS ASSAY
OUY
Trichomonas Vaginalis Nucleic Acid Amplification Test System
6d
Not Cleared
Apr 08, 2011
DENV DETECT IGM CAPTURE ELISA
OSU
Dengue Serological Reagents
170d
Cleared
Apr 07, 2011
XPERT C. DIFFICLE/EPI ASSAY
OMN
C. Difficile Nucleic Acid Amplification Test Assay
73d
Cleared
Mar 18, 2011
BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DNA ASSAYS
OQO
Herpes Simplex Virus Nucleic Acid Amplification Assay
81d
Cleared
Feb 24, 2011
ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10
OMN
C. Difficile Nucleic Acid Amplification Test Assay
52d
Not Cleared
Feb 23, 2011
RIDASCREEN NOROVIRUS 3RD GENERATION EIA
OUC
Norovirus Serological Reagent
7d
Cleared
Feb 10, 2011
ZEUS SCIENTIFIC, INC. TREPONEMA PALLIDUM IGG TEST SYSTEM
LIP
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
182d
Cleared
Jan 25, 2011
MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTION AND TRANSPORT DEVICE
LIO
Device, Specimen Collection
28d
Cleared
Jan 21, 2011
MAGO 4S
LFX
Enzyme Linked Immunoabsorbent Assay, Rubella
477d
Cleared
Jan 21, 2011
LIAISON XL ANALYZER MODEL 10050
LOL
Hepatitis A Test (antibody And Igm Antibody)
51d
Cleared
Jan 13, 2011
PLATELIA ASPERGILLUS EIA MODEL 62793
NOM
Antigen, Galactomannan, Aspergillus Spp.
412d
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 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
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 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
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