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
Feb 06, 2012
ARTUS INFL A/B RG RT-PCR KIT
OCC
Respiratory Virus Panel Nucleic Acid Assay System
88d
Cleared
Feb 01, 2012
GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT
LYR
Helicobacter Pylori
308d
Cleared
Jan 24, 2012
COBAS 4800 CT / NG TEST
MKZ
Dna Probe, Nucleic Acid Amplification, Chlamydia
298d
Cleared
Jan 20, 2012
TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS
LIP
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
158d
Not Cleared
Jan 20, 2012
STRATIFY JCV(TM) ANTIBODY
OYP
Anti-jcv Antibody Detection Assay
14d
Cleared
Dec 22, 2011
QUIDEL MOLECULAR INFLUENZA A + B ASSAY
OCC
Respiratory Virus Panel Nucleic Acid Assay System
147d
Cleared
Dec 16, 2011
IMMUNOCARD C. DIFFICILE GDH
MCB
Antigen, C. Difficile
151d
Cleared
Dec 16, 2011
VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S)
NQX
System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
115d
Cleared
Dec 15, 2011
QUIDEL MOLECULAR HMPV ASSAY
OEM
Human Metapneumovirus (hmpv) Rna Assay System
108d
Cleared
Dec 05, 2011
ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT
NJR
Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
133d
Cleared
Nov 30, 2011
VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOAZOLE
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
321d
Cleared
Nov 16, 2011
VIZION
JWY
Manual Antimicrobial Susceptibility Test Systems
99d
Cleared
Nov 09, 2011
ASIMANAGER - AT
JQT
Densitometer/scanner (integrating, Reflectance, Tlc, Radiochromat.) Clinica
177d
Cleared
Nov 08, 2011
SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES
JWY
Manual Antimicrobial Susceptibility Test Systems
151d
Cleared
Oct 28, 2011
BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B
PSZ
Devices Detecting Influenza A, B, And C Virus Antigens
80d
Cleared
Oct 26, 2011
VITEK 2 STREPTOCOCCUS PENICILLIN
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
105d
Cleared
Oct 24, 2011
SOFIA ANALYZER AND INFLUENZA A+B FIA
PSZ
Devices Detecting Influenza A, B, And C Virus Antigens
88d
Cleared
Oct 21, 2011
VRESELECT CULTURE MEDIUM
JSO
Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
308d
Cleared
Oct 20, 2011
BD GENEOHM VANR ASSAY
NIJ
System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species
422d
Cleared
Oct 18, 2011
VITEK 2 STREPTOCOCCUS INDUCIBLE CLINDAMYCIN RESISTANCE
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
105d
Cleared
Oct 18, 2011
CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM)
JTN
Susceptibility Test Discs, Antimicrobial
42d
Cleared
Oct 14, 2011
VITEK 2 SYSTEMS (PC) 5.02 SOFTWARE
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
295d
Cleared
Oct 03, 2011
VITEK 2 STREPTOCOCCUS LEVOFLOXACIN
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
61d
Cleared
Sep 27, 2011
ISOAMP HSV ASSAY
OQO
Herpes Simplex Virus Nucleic Acid Amplification Assay
81d
Cleared
Sep 27, 2011
VITEK(R) 2 STREPTOCOCCUS CLINDAMYCIN
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
63d
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