POC — System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen Class II
FDA product code POC covers "System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen", a Class II medical device regulated under 21 CFR 866.1640. Submissions are reviewed by the Microbiology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- POC
- Device Class
- Class II
- Regulation Number
- 866.1640
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Definition
To detect the presence of genetic markers of antimicrobial resistance by testing directly from clinical specimens using nucleic acid amplification technology.