Definition: The Device Is Used For The Measurement, In Human Stool, Of Fecal Calprotectin, A Neutrophilic Protein That Is A Marker Of Mucosal Inflammation. The Device Can Be Used As An Aid In The Diagnosis Of Inflammatory Bowel Disease (ibd), Crohn's Disease And
Device Type ID | 3076 |
Device Name | Calprotectin, Fecal |
Physical State | N/a |
Technical Method | Enzyme-linked Immunosorbent Assay (ELISA) |
Target Area | N/a |
Regulation Description | Fecal Calprotectin Immunological Test System. |
Regulation Medical Specialty | Immunology |
Review Panel | Immunology |
Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
Submission Type | 510(k) |
CFR Regulation Number | 866.5180 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | NXO |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 3076 |
Device | Calprotectin, Fecal |
Product Code | NXO |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Fecal Calprotectin Immunological Test System. |
CFR Regulation Number | 866.5180 [🔎] |
Premarket Reviews | ||
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Manufacturer | Decision | |
BUHLMANN LABORATORIES AG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DIASORIN | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DIASORIN S.P.A | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EUROSPITAL S.P.A. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
INOVA DIAGNOSTICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 |