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
May 20, 2011
JBAIDS Q FEVER DETECTION KIT
OVF
Assay, Direct, Nucleic Acid Amplification, Q Fever
200d
Cleared
May 20, 2011
ZEUS ELISA HSV GG-2 IGG TEST SYSTEM
MYF
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
163d
Cleared
May 18, 2011
VIDAS TOXO IGG AVIDITY
LGD
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
310d
Cleared
May 17, 2011
RPS ADENO DETECTOR PLUS
GOD
Antigens, Cf (including Cf Control), Adenovirus 1-33
63d
Cleared
May 16, 2011
ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 UG/ML
JWY
Manual Antimicrobial Susceptibility Test Systems
255d
Cleared
May 05, 2011
KEYPATH(TM) MRSA/MSSA BLOOD CULTURE TEST- BT
OUS
Methicillin Resistant Staphylococcus Aureus/methicillin Susceptible Staphylococcus Aureus Blood Culture Test Bt
260d
Cleared
May 04, 2011
ADVIA CENTAUR TOXOPLASMA IGG (TOXO G)
LGD
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
229d
Cleared
May 04, 2011
HARDYCHROM MRSA
JSO
Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
215d
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 17, 2011
FILMARRAY RESPIRATORY PANEL (RP)
OCC
Respiratory Virus Panel Nucleic Acid Assay System
112d
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
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