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
Jul 05, 2013
SOFIA INFLUENZA A+B FIA
GNX
Antigens, Cf (including Cf Control), Influenza Virus A, B, C
32d
Cleared
Jul 05, 2013
QUICK VUE INFLUENZA
GNX
Antigens, Cf (including Cf Control), Influenza Virus A, B, C
32d
Cleared
Jun 28, 2013
QUICKVUE INFLUENZA A+B
GNX
Antigens, Cf (including Cf Control), Influenza Virus A, B, C
25d
Cleared
Jun 27, 2013
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- IMIPENEM (0.0625-32 UG/ML)
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
234d
Cleared
Jun 26, 2013
BD PHOENIX AUTOMATED MICROIOLOGY SYSTEM- ERTAPENEM 0.0625-8 UG/ML-GN
LON
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
250d
Cleared
Jun 21, 2013
FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL
PEN
Gram-negative Bacteria And Associated Resistance Markers
80d
Cleared
Jun 20, 2013
XPERT MRSA/SA BLOOD CULTURE ASSAY
NQX
System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
80d
Cleared
Jun 17, 2013
SOFIA STREP A FIA
GTY
Antigens, All Groups, Streptococcus Spp.
189d
Cleared
Jun 05, 2013
ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA EXTERNAL CONTROLS KIT
OZX
Mycoplasma Pneumoniae Dna Assay System
211d
Cleared
Jun 04, 2013
VIDAS LYME IGM
LSR
Reagent, Borrelia Serological Reagent
251d
Cleared
May 22, 2013
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
OQW
2009 H1n1 Influenza Virus (swine Origin), Nucleic Acid Or Antigen, Detection And Identification
79d
Cleared
May 22, 2013
BREATHID HP SYSTEM
MSQ
Test, Urea (breath Or Blood)
83d
Cleared
May 13, 2013
BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic)
MDB
System, Blood Culturing
145d
Cleared
Apr 02, 2013
BD MAX CDIFF ASSAY, BD MAX INSTRUMENT
OZN
C. Difficile Toxin Gene Amplification Assay
36d
Cleared
Mar 21, 2013
XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP) LUMINEX MAGPIX
PCH
Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System
265d
Cleared
Mar 14, 2013
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - CEFTAROLINE
LTT
Panels, Test, Susceptibility, Antimicrobial
84d
Cleared
Mar 08, 2013
QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAY
OZN
C. Difficile Toxin Gene Amplification Assay
72d
Cleared
Mar 08, 2013
QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT
OOI
Real Time Nucleic Acid Amplification System
77d
Cleared
Mar 08, 2013
QUIDEL MOLECULAR RSV + HMPV ASSAY
OEM
Human Metapneumovirus (hmpv) Rna Assay System
227d
Cleared
Mar 05, 2013
VIDAS LYME IGG
LSR
Reagent, Borrelia Serological Reagent
160d
Cleared
Mar 01, 2013
UNIGOLD GIARDIA
MHI
Giardia Spp.
423d
Cleared
Feb 11, 2013
FILMARRAY RESPIRATORY PANEL (RP)
OCC
Respiratory Virus Panel Nucleic Acid Assay System
80d
Cleared
Feb 08, 2013
ADENOVIRUS R-GENE US
OCC
Respiratory Virus Panel Nucleic Acid Assay System
221d
Cleared
Feb 08, 2013
UNI-GOLD CRYPTOSPORIDIUM
MHJ
Cryptosporidium Spp.
255d
Cleared
Feb 06, 2013
BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF GROUP A STREP
GTY
Antigens, All Groups, Streptococcus Spp.
154d
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