PRE
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3215
- Medical specialty
- Microbiology
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| TriVerity (K241676) | Inflammatix, Inc. | 2025-01-10 |
| SeptiCyte RAPID (K232095) | Immunexpress, Inc. | 2023-12-15 |
| SeptiCyte RAPID (K203748) | Immunexpress, Inc. | 2021-11-29 |
| SeptiCyte LAB (K163260) | Immunexpress, Inc. | 2017-02-17 |
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Every clearance here is in the API, with alerts when new ones post.