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.
| Device Type ID | 3530 |
| Device Name | C. Difficile Nucleic Acid Amplification Test Assay |
| Physical State | KIt Containing DNA Positive Control, DNA Internal Control, Buffer Containing Deoxyribonucleic Acids And Magnesium Chloride, DNA Polymerase, DNA Primers And DNA Probes |
| Technical Method | Nucleic Acid Amplification Test |
| Target Area | Stool Samples |
| Regulation Description | Microorganism Differentiation And Identification Device. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
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| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 866.2660 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | OMN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |