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
7048
Total
6986
Cleared
159d
Avg (2y)
1976
Since
1404 Microbiology devices
Cleared
Apr 03, 1987
CHOCOLATE AGAR W/BACITRACIN (HAEM. ISOL. AGAR)
JSJ
Culture Media, Selective And Non-differential
16d
Cleared
Apr 03, 1987
BRILLIANT GREEN AGAR
JSI
Culture Media, Selective And Differential
16d
Cleared
Apr 03, 1987
CLED AGAR
JSH
Culture Media, Non-selective And Differential
16d
Cleared
Apr 03, 1987
CYSTINE TRYPTIC AGAR W/O CARBOHYDRATES
JSE
Culture Media, Multiple Biochemical Test
16d
Cleared
Apr 03, 1987
CHOCOLATE MUELLER HINTON AGAR
JTZ
Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth
16d
Cleared
Apr 03, 1987
TRYPTIC SOY AGAR
JSG
Culture Media, Non-selective And Non-differential
16d
Cleared
Mar 17, 1987
NORFLOXACIN 10 MCG SENSI DISC
JTN
Susceptibility Test Discs, Antimicrobial
102d
Cleared
Mar 10, 1987
DIRECTIGEN MENINGITIS COMBO TEST & (B) STREP TEST
GTZ
Antisera, All Groups, Streptococcus Spp.
56d
Cleared
Feb 26, 1987
ABBOTT TESTPACK(TM) STREP A POSITIVE CONTROL
GTY
Antigens, All Groups, Streptococcus Spp.
83d
Cleared
Feb 25, 1987
MICROTRAK CHLAMYDIA TRACHOMATIS DIRECT SPECI. TEST
LJP
Antiserum, Fluorescent, Chlamydia Trachomatis
75d
Cleared
Feb 20, 1987
ACCUPOINT TOXO
LGD
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
53d
Cleared
Feb 13, 1987
AZTREONAM 30 MCG. SENSI-DISC
JTN
Susceptibility Test Discs, Antimicrobial
52d
Cleared
Feb 06, 1987
BACTEC(R) NR-660 HIGH PERFORMANCE SYSTEM
JTA
Monitor, Microbial Growth
45d
Cleared
Feb 03, 1987
GC-LECT(TM)
JTY
Culture Media, For Isolation Of Pathogenic Neisseria
56d
Cleared
Dec 11, 1986
BBL CAMPYSLIDE(TM) TEST
LQP
Campylobacter Spp.
57d
Cleared
Oct 31, 1986
CANDIDA BROM CRESOL GREEN AGAR
JSI
Culture Media, Selective And Differential
11d
Cleared
Oct 31, 1986
MODIFIED N.Y.C. FERMENTATION MEDIUM BASE
JTY
Culture Media, For Isolation Of Pathogenic Neisseria
11d
Cleared
Oct 31, 1986
TRYCOPHYTON AGARS
JSH
Culture Media, Non-selective And Differential
10d
Cleared
Sep 30, 1986
XANTHINE/TYROSINE/CASEIN AGAR
JSH
Culture Media, Non-selective And Differential
18d
Cleared
Sep 30, 1986
BIRD SEED AGAR
JSH
Culture Media, Non-selective And Differential
18d
Cleared
Sep 30, 1986
STARCH AGAR W/BROM CRESOL PURPLE
JSH
Culture Media, Non-selective And Differential
15d
Cleared
Sep 30, 1986
MOTILITY INDOLE LYSINE SULFIDE (MILS) MEDIUM
JSH
Culture Media, Non-selective And Differential
15d
Cleared
Sep 30, 1986
ONPG SOLUTION
JTO
Discs, Strips And Reagents, Microorganism Differentiation
15d
Cleared
Sep 30, 1986
BUFFERED GLYCEROL SALINE
JSM
Culture Media, Non-propagating Transport
15d
Cleared
Sep 30, 1986
GI MOTILITY TEST MEDIUM W/TTC
JSS
Kit, Identification, Enterobacteriaceae
15d
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