OMN · Class I · 21 CFR 866.2660

FDA Product Code OMN: C. Difficile Nucleic Acid Amplification Test Assay

In Vitro Diagnostic Test For The Qualitative Detection Of Toxigenic Clostridium Difficile Nucleic Acids Isolated And Purified From Stool Specimens Obtained From Symptomatic Patients.

Leading manufacturers include Meridian Bioscience, Inc., Great Basin Scientific and Cepheid.

5
Total
4
Cleared
85d
Avg days
2010
Since

FDA 510(k) Cleared C. Difficile Nucleic Acid Amplification Test Assay Devices (Product Code OMN)

5 devices
1–5 of 5
Not Cleared Apr 30, 2012
PORTRAIT ANALYZER
DEN120013
Great Basin Scientific
Microbiology · 59d
Cleared Apr 04, 2012
SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT
K113433
Focus Diagnostics, Inc.
Microbiology · 135d
Cleared Apr 07, 2011
XPERT C. DIFFICLE/EPI ASSAY
K110203
Cepheid
Microbiology · 73d
Cleared Feb 24, 2011
ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10
K110012
Meridian Bioscience, Inc.
Microbiology · 52d
Cleared Jul 09, 2010
ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920
K100818
Meridian Bioscience, Inc.
Microbiology · 108d

About Product Code OMN - Regulatory Context