PRE — Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers Class II
FDA product code PRE covers "Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers", a Class II medical device regulated under 21 CFR 866.3215. 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
- PRE
- Device Class
- Class II
- Regulation Number
- 866.3215
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Definition
A quantitative gene expression assay using reverse transcription polymerase chain reaction to quantify the relative expression levels of host response genes isolated from whole blood.