Immunoassay For Host Biomarkers Of Infection
The Immunoassay for Host Biomarkers of Infection is a semi-quantitative immunoassay that quantifies the relative levels of host response proteins isolated from serum or similar specimens, intended to provide information about the host immune response to infection as an aid in clinical decision-making. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 866.3215 in the Microbiology specialty. It carries product code QPS and is not an implant and not life-sustaining.
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Basic Information
- Product Code
- QPS
- Device Class
- FDA class 2
- Regulation Number
- 866.3215
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
Definition
A semi-quantitative immunoassay that quantifies the relative levels of host response proteins isolated from serum or similar specimens.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K230944 | MeMed BV | Jun 30, 2023 | Substantially Equivalent | MeMed Diagnostics, Ltd. |
| K222332 | MeMed BV | Mar 23, 2023 | Substantially Equivalent | MeMed Diagnostics, Ltd. |
| K213936 | LIAISON MeMed BV, LIAISON MeMed BV Control Set | Jul 14, 2022 | Substantially Equivalent | DiaSorin, Inc. |
| K210254 | MeMed BV | Sep 01, 2021 | Substantially Equivalent | MeMed Diagnostics, Ltd. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.