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
5940 Microbiology devices
Cleared
Jun 10, 1987
RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122
JTL
Plasma, Coagulase, Human, Horse And Rabbit
93d
Cleared
Jun 10, 1987
ORICULT-N CULTURE-PADDLE
JSI
Culture Media, Selective And Differential
13d
Cleared
Jun 04, 1987
ADENOLEX (R) LATEX AGGLUTINATION TEST
GOD
Antigens, Cf (including Cf Control), Adenovirus 1-33
191d
Cleared
Jun 02, 1987
MUCATE AGAR, SLANTS AND MUCATE BROTH
JSH
Culture Media, Non-selective And Differential
7d
Cleared
May 29, 1987
NOVAPATH C. TRACHOMATIS DIRECT SPEC COLLECTION KIT
LIO
Device, Specimen Collection
16d
Cleared
May 28, 1987
LD PRESUMPTO QUAD
JTO
Discs, Strips And Reagents, Microorganism Differentiation
13d
Cleared
May 26, 1987
SORBITOL MACCONKEY (SMAC) AGAR, DRI & PRE-FORM
JSH
Culture Media, Non-selective And Differential
13d
Cleared
May 21, 1987
GBNA MEDIUM
JSJ
Culture Media, Selective And Non-differential
15d
Cleared
May 20, 1987
ARYLSULFATASE BROTH
JSH
Culture Media, Non-selective And Differential
19d
Cleared
May 20, 1987
MRS AGAR AND MRS BROTH
JSJ
Culture Media, Selective And Non-differential
19d
Cleared
May 15, 1987
TICARCILLIN/CLVULINIC ACID 85 MCG SUSCEPTIBILITY D
JTN
Susceptibility Test Discs, Antimicrobial
16d
Cleared
May 15, 1987
ANAEROBIC TRANSPORT POUCH (CATALYST-FREE)
KZJ
Device, Gas Generating
14d
Cleared
May 13, 1987
TODD HEWITT W/CNA (LIM BROTH)
JSD
Culture Media, Selective Broth
30d
Cleared
May 13, 1987
ALKALINE PEPTONE WATER
JSD
Culture Media, Selective Broth
16d
Cleared
May 08, 1987
IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPING TEST
GQN
Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2
86d
Cleared
Apr 29, 1987
CHLAMYDIA-CHECK(TM) DIRECT & CULTURE CONFIR. KIT
LJP
Antiserum, Fluorescent, Chlamydia Trachomatis
190d
Cleared
Apr 29, 1987
CHLAMYDIAZYME DIAGNOSTIC KIT
LJC
Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group)
140d
Cleared
Apr 29, 1987
BROTH ELUTION DISKS CLINDAMYCIN 10MCG
JTN
Susceptibility Test Discs, Antimicrobial
104d
Cleared
Apr 29, 1987
DISPENS-O-DISC BROTH ELUTION DISKS METRON. 80 MCG
JTN
Susceptibility Test Discs, Antimicrobial
99d
Cleared
Apr 29, 1987
MONABRITE CHLAMYDIA TRACHOMATIS DIR. SPECIMEN TEST
LJP
Antiserum, Fluorescent, Chlamydia Trachomatis
51d
Cleared
Apr 29, 1987
MARTIN-LEWIS AGAR W/REDUCED VANCOMYCIN C0226
JTY
Culture Media, For Isolation Of Pathogenic Neisseria
9d
Cleared
Apr 28, 1987
TOXOPLASMA IGM MICROASSAY
LGD
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
61d
Cleared
Apr 28, 1987
BACTO(R) STREP GROUP KIT
GTZ
Antisera, All Groups, Streptococcus Spp.
56d
Cleared
Apr 22, 1987
ENZYGNOST ANTI-VZV IGG TEST
GQX
Antiserum, Cf, Varicella-zoster
239d
Cleared
Apr 22, 1987
BACTIGEN SALMONELLA-SHIGELLA TEST
GRM
Antisera, All Groups, Salmonella Spp.
50d
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