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
7067
Total
7005
Cleared
149d
Avg (2y)
1976
Since
5931 Microbiology devices
Cleared
Jun 18, 1996
SAS SALMONELLA O GROUP X FACTOR 47 ANTISERUM
GRM
Antisera, All Groups, Salmonella Spp.
29d
Cleared
Jun 18, 1996
SAS SALMONELLA O POLY B ANTISERUM
GRM
Antisera, All Groups, Salmonella Spp.
29d
Cleared
Jun 17, 1996
IMMULITE CMV IGG
LFZ
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
490d
Cleared
Jun 17, 1996
VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAINFLUENZA VIRUSES
GNT
Antigens, Ha (including Ha Control), Influenza Virus A, B, C
479d
Cleared
Jun 17, 1996
SERAQUEST TOXOPLASMA IGG
LGD
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
158d
Cleared
Jun 17, 1996
SYPHILIS IGG HUMAN SERUM CONTROLS
LIP
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
137d
Cleared
Jun 17, 1996
COLISCREEN
JTO
Discs, Strips And Reagents, Microorganism Differentiation
83d
Cleared
Jun 07, 1996
MARDX LYME DISEASE (IGM) MARBLOT STRIP TEST SYSTEM
LSR
Reagent, Borrelia Serological Reagent
421d
Cleared
Jun 07, 1996
CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY
LIN
Antisera, Conjugated Fluorescent, Cytomegalovirus
414d
Cleared
Jun 07, 1996
LMD CRYPTOSPORIDIUM ANTIGEN DETECTION
MHJ
Cryptosporidium Spp.
199d
Cleared
Jun 07, 1996
FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT DIAGNOSTICS)ANDCONTROLS FOR FLEXPACK HP (ABBOTT DIAGNOSTICS)
LYR
Helicobacter Pylori
143d
Cleared
Jun 05, 1996
MARDX LYME DISEASE (IGG) MARBLOT STRIP TEST SYSTEM
LSR
Reagent, Borrelia Serological Reagent
468d
Cleared
May 31, 1996
SAS SHIGELLA SONNEI FORM II ANTISERUM
GNB
Antisera, All Types, Shigella Spp.
39d
Cleared
May 30, 1996
IMX SELECT CHLAMYDIA
LJC
Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group)
891d
Cleared
May 30, 1996
DIRECTIGEN MENINGITIS COMBO TEST
GTJ
Antisera, All Groups, N. Meningitidis
346d
Cleared
May 30, 1996
H292 CELL CULTURE
KIR
Cells, Animal And Human, Cultured
86d
Cleared
May 30, 1996
MICROSCAN RAPID GRAM-NEGATIVE INDENTIFICATION TYPE 3 PANEL
LRH
Instrument For Auto Reader Of Overnight Microorganism Identification System
77d
Cleared
May 23, 1996
VISUWELL REAGIN II
GMQ
Antigens, Nontreponemal, All
339d
Cleared
May 23, 1996
PREMIER HSV PLUS
LGC
Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific
281d
Cleared
May 21, 1996
BACTEC(R) 9000TB SYSTEM
MDB
System, Blood Culturing
515d
Cleared
May 21, 1996
HELISAL RAPID BLOOD TEST
LYR
Helicobacter Pylori
295d
Cleared
May 20, 1996
ETEST SUBMISSION FOR IMIPENEM
JWY
Manual Antimicrobial Susceptibility Test Systems
70d
Cleared
May 20, 1996
ETEST SUBMISSION FOR VANCOMYCIN
JWY
Manual Antimicrobial Susceptibility Test Systems
70d
Cleared
May 20, 1996
SAS SHIGELLA BOYDII TYPE 11 ANTISERUM (3/100/1000ML)
GNB
Antisera, All Types, Shigella Spp.
28d
Cleared
May 20, 1996
SAS SHIGELLA BOYDII TYPE 12 ANTISERUM
GNB
Antisera, All Types, Shigella Spp.
28d
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