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Immunoassay For Host Biomarkers Of Sepsis

FDA product code SCX · 1 cleared devices

Class 2 Microbiology
Regulation
21 CFR 866.3215
Review panel
MI
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2024-09-25 – 2024-09-25

A semi-quantitative immunoassay that measures the relative levels of host response proteins isolated from host blood or similar specimens.

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