510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OMNClass I

C. Difficile Nucleic Acid Amplification Test Assay

21 CFR 866.2660 / Microbiology
FDA source (opens on fda.gov)

OMN is the FDA product code for C. Difficile Nucleic Acid Amplification Test Assay, a class I device type, regulated under 21 CFR 866.2660. FDA's definition for this code reads: "In vitro diagnostic test for the qualitative detection of toxigenic clostridium difficile nucleic acids isolated and purified from stool specimens obtained from symptomatic patients". As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
OMN
Device name
C. Difficile Nucleic Acid Amplification Test Assay
FDA definition
In vitro diagnostic test for the qualitative detection of toxigenic clostridium difficile nucleic acids isolated and purified from stool specimens obtained from symptomatic patients.
Regulation
21 CFR 866.2660
Device class
Class I
Review panel
Microbiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
5
Ingested recalls
2

Clearances, product code OMN

By decision year
5 clearances under product code OMN with a decision year between 2010 and 2012, 2011 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code OMN by decision year
YearClearances
20101
20112
20122

Applicants with the most clearances

Product code OMN
Applicants holding the most 510(k) clearances under product code OMN
ApplicantClearances
Meridian Bioscience Inc2
Cepheid1
DiaSorin Molecular LLC1
Great Basin Scientific, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code