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
Mar 29, 2010
TELAVANCIN 30 UG, BBL SENSI-DISC
JTN
Susceptibility Test Discs, Antimicrobial
14d
Cleared
Mar 12, 2010
ELECSYS RUBELLA IGM IMMUNOASSAY
LFX
Enzyme Linked Immunoabsorbent Assay, Rubella
220d
Cleared
Mar 12, 2010
C. ALBICANS/C. GLABRATA PNA FISH
NZS
Fish (fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast
183d
Cleared
Mar 12, 2010
LIGHT DIAGNOSTICS HUMAN METAPNEUMOVIRUS DFA KIT, MODEL CATALOG NUMBER 3124
OMG
Antisera, Fluorescent, Human Metapneumovirus
88d
Cleared
Mar 09, 2010
POC-AS10 AUTO SAMPLER
MSQ
Test, Urea (breath Or Blood)
176d
Cleared
Mar 02, 2010
CHROMID VRE AGAR, MODEL: REF 43 851
JSO
Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
326d
Cleared
Feb 25, 2010
SENSITIVE HAEMOPHILUS INFLUENZAE, STREPTOCOCCUS PNEUMONIA, (HP) MIC SUSCEPTIBILITY PLATES
JWY
Manual Antimicrobial Susceptibility Test Systems
83d
Cleared
Feb 24, 2010
CLEARVIEW EXACT PBP2A TEST, MODEL 891-000
MYI
System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies
252d
Cleared
Feb 23, 2010
SAS FLUALERT A&B, SAS INFLUENZA A TEST
PSZ
Devices Detecting Influenza A, B, And C Virus Antigens
28d
Cleared
Feb 17, 2010
SENSITITRE 18-24HR SUSCEPTIBILITY PLATES
JWY
Manual Antimicrobial Susceptibility Test Systems
63d
Cleared
Jan 26, 2010
MICROSCAN MICROSTREP PLUS, MODEL B1027-201
LTT
Panels, Test, Susceptibility, Antimicrobial
209d
Cleared
Jan 19, 2010
C. ALBICANS PNA FISH
NZS
Fish (fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast
144d
Cleared
Jan 08, 2010
HARDYDISK AST TELAVANCIN,30UG
JTN
Susceptibility Test Discs, Antimicrobial
28d
Cleared
Dec 23, 2009
D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT
GQS
Antigens, Cf (including Cf Control), Parainfluenza Virus 1-4
51d
Cleared
Dec 17, 2009
Xpert VanA Assay
NIJ
System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species
84d
Cleared
Dec 16, 2009
BINAXNOX STAPHYLOCOCCUS AUREUS TEST
JWX
Kit, Screening, Staphylococcus Aureus
254d
Cleared
Dec 16, 2009
IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM
LIP
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
222d
Cleared
Dec 16, 2009
E.COLI/P. AERUGINOSA PNA FISH
JSS
Kit, Identification, Enterobacteriaceae
146d
Cleared
Dec 16, 2009
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
JWY
Manual Antimicrobial Susceptibility Test Systems
128d
Cleared
Dec 15, 2009
BD GENEOHM MRSA ACP ASSAY
NQX
System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
50d
Cleared
Dec 04, 2009
D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT
OMG
Antisera, Fluorescent, Human Metapneumovirus
51d
Cleared
Nov 25, 2009
VIRAMED BIOTECH AG BORRELIA B31 IGG VIRASTRIPE, MODEL V-BBSGUS
LSR
Reagent, Borrelia Serological Reagent
84d
Cleared
Nov 23, 2009
S. AUREUS/CNS PNA FISH, MODEL KT005
NXX
Fish (fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus
125d
Cleared
Nov 20, 2009
PROPARAFLU+ASSAY
OOU
Parainfluenza Multiplex Nucleic Acid Assay
221d
Cleared
Nov 17, 2009
VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM
OCC
Respiratory Virus Panel Nucleic Acid Assay System
22d
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