QPS
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Immunoassay For Host Biomarkers Of Infection
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3215
- Medical specialty
- Microbiology
- FDA definition
- A semi-quantitative immunoassay that quantifies the relative levels of host response proteins isolated from serum or similar specimens.
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| Record | Firm | Date |
|---|---|---|
| MeMed BV (K230944) | MeMed Diagnostics, Ltd. | 2023-06-30 |
| MeMed BV (K222332) | MeMed Diagnostics, Ltd. | 2023-03-23 |
| LIAISON MeMed BV, LIAISON MeMed BV Control Set (K213936) | DiaSorin, Inc. | 2022-07-14 |
| MeMed BV (K210254) | MeMed Diagnostics, Ltd. | 2021-09-01 |
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Every clearance here is in the API, with alerts when new ones post.