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 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

About Product Code OMN - Regulatory Context