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
Aug 17, 1988
SCEPTOR EXTEN. OF CONCENTRATION RANGE: PENCILLIN
JWY
Manual Antimicrobial Susceptibility Test Systems
36d
Cleared
Aug 17, 1988
SCEPTOR NEW ANTIMICROBIAL AGENT: IMIPENEM
JWY
Manual Antimicrobial Susceptibility Test Systems
36d
Cleared
Aug 15, 1988
FASTIDIOUS INOCULUM BROTH
JSD
Culture Media, Selective Broth
33d
Cleared
Jul 25, 1988
ABBOTT TESTPACK CHLAMYDIA
LJC
Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group)
150d
Cleared
Jul 18, 1988
SCEPTOR GRAM-NEGATIVE URINE ISOLATE MIC/ID PANEL
JWY
Manual Antimicrobial Susceptibility Test Systems
46d
Cleared
Jul 14, 1988
SCEPTOR - NEW ANTIMICROBIAL AGENT: CEFACLOR
JWY
Manual Antimicrobial Susceptibility Test Systems
84d
Cleared
Jul 14, 1988
ABBOTT TESTPACK(TM) CHLAMYDIA POSITIVE CONTROL
LJC
Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group)
23d
Cleared
Jul 12, 1988
SCEPTOR ENTERIC MIC PANEL (REVISED 4/88)
JWY
Manual Antimicrobial Susceptibility Test Systems
40d
Cleared
Jul 12, 1988
SCEPTOR ENTERIC MIC/ID PANEL (REVISED 4/88)
JWY
Manual Antimicrobial Susceptibility Test Systems
40d
Cleared
Jul 12, 1988
ABBOTT TESTPACK(TM) GONORRHEA POSITIVE CONTROL
LIR
Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae
21d
Cleared
Jul 08, 1988
DU PONT VCA-IGM ANTIBODY ELISA KIT
LJN
Antibody Igm, If, Epstein-barr Virus
203d
Cleared
Jul 08, 1988
SCEPTOR- NEW ANTIMICROBIAL AGENT: NORFLOXACIN
JWY
Manual Antimicrobial Susceptibility Test Systems
67d
Cleared
Jun 22, 1988
ABBOTT TESTPACK(TM) RSV POSITIVE CONTROL
GQG
Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus
22d
Cleared
May 23, 1988
CHLAMYDIAZYME(TM)
LJC
Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group)
110d
Cleared
May 13, 1988
ABBOTT CMV-M EIA KIT
LKQ
Antibody Igm,if, Cytomegalovirus Virus
296d
Cleared
May 06, 1988
ABBOTT TESTPACK RSV
GQG
Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus
206d
Cleared
May 06, 1988
RESUBMITTED ABBOTT TESTPACK ROTAVIRUS
LIQ
Enzyme Linked Immunoabsorbent Assay, Rotavirus
66d
Cleared
Apr 21, 1988
KODAK SURECELL STREP A TEST KIT
GTZ
Antisera, All Groups, Streptococcus Spp.
15d
Cleared
Apr 19, 1988
MICROTRAK CMV CULTURE CONFIRMATION TEST
GQH
Antigen, Cf (including Cf Control), Cytomegalovirus
85d
Cleared
Apr 12, 1988
GRAM NEGATIVE MIC/COMBO PANELS
JWY
Manual Antimicrobial Susceptibility Test Systems
71d
Cleared
Mar 24, 1988
BACTEC(R) NR26 AND BACTEC(R) NR 27 CULTURE MEDIA
JSG
Culture Media, Non-selective And Non-differential
9d
Cleared
Feb 18, 1988
DU PONT HERPCHEK HSV ANTIGEN ELISA TEST KIT
GQN
Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2
227d
Cleared
Feb 18, 1988
MICROTRAK HSV CULTURE IDENTIFICATION TEST
GQN
Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2
16d
Cleared
Feb 04, 1988
MICROTRAK HSV 1/HSV 2 CULTURE IDENTI./TYPING TEST
GON
Antigen, Cf (including Cf Control), Rubella
22d
Cleared
Jan 11, 1988
GRAM - & GRAM + MIC/COMBO & BREAKPOINT/COMBO PANEL
JWY
Manual Antimicrobial Susceptibility Test Systems
42d
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