Part 866 Subpart D—Serological Reagents
FDA submissions for Part 866 Subpart D—Serological Reagents in the Immunology (IM) review panel, including product codes and regulations.
Section range: §§ 866.3176–866.4000
CFR Part: 866
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| SGW | Device To Detect Antibodies To Hepatitis D Virus | 866.3176 | 2 | 1 |
| OUY | Trichomonas Vaginalis Nucleic Acid Amplification Test System | 866.3860 | 2 | 10 |
| NHS | Assay, Genotype, Hiv Drug Resistance, In Vitro | 866.3950 | 2 | 0 |
| QVR | Multiplex Nucleic Acid Detection System For Biothreat Agents | 866.4000 | 2 | 2 |
| SGA | Biothreat Microbial Agent Nucleic Acid Detection Test | 866.4000 | 2 | 2 |
