FDA Review Panel · MI

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
2451–2475 of 7095
Cleared Dec 22, 1997
ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM
K972406 · Immunoprobe, Inc.
GOD · Antigens, Cf (including Cf Control), Adenovirus 1-33 · 179d
Cleared Dec 22, 1997
IMAGEN RESPIRATORY SCREEN
K973954 · Dako Diagnostics , Ltd.
GNW · Antisera, Cf, Influenza Virus A, B, C · 74d
Cleared Dec 11, 1997
ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROL
K974261 · Boston Biomedica, Inc.
LJK · Antisera, If, Toxoplasma Gondii · 28d
Cleared Dec 02, 1997
QUANTA LITE TOXOPLASMA IGG
K971441 · Inova Diagnostics, Inc.
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 228d
Cleared Dec 02, 1997
BACT/ALERT FAN CULTURE BOTTLES
K973325 · Organon Teknika Corp.
MDB · System, Blood Culturing · 89d
Cleared Dec 01, 1997
QUANTA LITE CMV IGG ELISA
K971335 · Inova Diagnostics, Inc.
LFZ · Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus · 235d
Cleared Dec 01, 1997
CEFMETAZOLE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K973479 · Oxoid , Ltd.
JTN · Susceptibility Test Discs, Antimicrobial · 77d
Cleared Nov 18, 1997
ELVIS HSV ID/TYPING TEST SYSTEM
K971662 · Diagnostic Hybrids, Inc.
GQN · Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 · 203d
Cleared Nov 17, 1997
BACT/ALERT CULTURE BOTTLES
K973305 · Organon Teknika Corp.
MDB · System, Blood Culturing · 75d
Cleared Nov 14, 1997
PASCO MIC AND MIC/ID PANELS
K973317 · Pasco Laboratories, Inc.
LTT · Panels, Test, Susceptibility, Antimicrobial · 72d
Cleared Nov 13, 1997
SERODIA TP-PA
K971502 · Scimedx Tekfile Services
GMT · Antigens, Ha, Treponema Pallidum · 203d
Cleared Nov 05, 1997
SERAQUEST VZV IGG
K972295 · Quest Intl., Inc.
LFY · Enzyme Linked Immunoabsorbent Assay, Varicella-zoster · 139d
Cleared Nov 05, 1997
PASCO MIC AND MIC/ID PANELS
K973695 · Pasco Laboratories, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 40d
Cleared Nov 04, 1997
MUMPS IGG ELISA TESTY
K971857 · Gull Laboratories, Inc.
LJY · Enzyme Linked Immunoabsorbent Assay, Mumps Virus · 168d
Cleared Oct 29, 1997
THE MERETEK UBT BREATH TEST FOR H.PYLORI
K972352 · Meretek Diagnostics, Inc.
MSQ · Test, Urea (breath Or Blood) · 127d
Cleared Oct 22, 1997
TOXOPLASMA IGM ASSAY FOR THE BAYER IMMUNO1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
K971989 · Bayer Corp.
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 146d
Cleared Oct 21, 1997
SERAQUEST TOXOPLASMA IGM
K971672 · Quest Intl., Inc.
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 167d
Cleared Oct 16, 1997
QUIX RAPID E. COLI O157 STRIP TEST
K972156 · Guardian Scientific, Corp.
GMZ · Antigens, All Types, Escherichia Coli · 129d
Cleared Oct 10, 1997
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K972799 · Dade Microscan, Inc.
LTT · Panels, Test, Susceptibility, Antimicrobial · 74d
Cleared Oct 10, 1997
LOMEFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K973488 · Oxoid , Ltd.
JTN · Susceptibility Test Discs, Antimicrobial · 25d
Cleared Oct 10, 1997
LORACARBEF ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K973489 · Oxoid , Ltd.
JTN · Susceptibility Test Discs, Antimicrobial · 25d
Cleared Oct 08, 1997
SNAP SWAB CULTURE COLLECTION AND TRANSPORT SYSTEM
K972726 · Medical Packaging Corp.
JSM · Culture Media, Non-propagating Transport · 79d
Cleared Oct 08, 1997
ACCURUN 140 RUBELLA IGG POSITIVE CONTROL
K972986 · Boston Biomedica, Inc.
MJX · Kit, Serological, Positive Control · 58d
Cleared Oct 06, 1997
CEFPODOXIME ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K973487 · Oxoid , Ltd.
JTN · Susceptibility Test Discs, Antimicrobial · 21d
Cleared Oct 03, 1997
VIDAS ROTAVIRUS (RTV) ASSAY
K972895 · Biomerieux Vitek, Inc.
LIQ · Enzyme Linked Immunoabsorbent Assay, Rotavirus · 59d

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All categories 7095 JWY Manual Antimicrobial Susceptibility Test Systems 441 JTN Susceptibility Test Discs, Antimicrobial 323 JSJ Culture Media, Selective And Non-differential 299 LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation 291 JSI Culture Media, Selective And Differential 267 JTO Discs, Strips And Reagents, Microorganism Differentiation 239 JSG Culture Media, Non-selective And Non-differential 198 JSH Culture Media, Non-selective And Differential 142 LSR Reagent, Borrelia Serological Reagent 112 JSM Culture Media, Non-propagating Transport 110 LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii 104 GTZ Antisera, All Groups, Streptococcus Spp. 99 LFX Enzyme Linked Immunoabsorbent Assay, Rubella 92 LYR Helicobacter Pylori 91 JSF Culture Media, Single Biochemical Test 87