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) |
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 |