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.

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
No devices found for this product code.

About Product Code OMN - Regulatory Context