Definition: For The Detection Of Anti-outer Membrane Protein (anti-OMP) Antibodies In Human Serum. To Aid In The Diagnosis Of Crohn's Disease.
| Device Type ID | 3085 |
| Device Name | Antibodies, Outer-membrane Proteins |
| Physical State | Comprised Of Antigen Coated Microtiter Plate, Enzyme Conjugate, Substrate, Controls |
| Technical Method | Uses Enzyme-linked, Immunosorbent Assay (ELISA) To Identify The Presence Of Anti-OMP Antibodies. |
| Target Area | Human Serum |
| Regulation Description | Anti-Saccharomyces Cerevisiae (S. Cerevisiae) Antibody (ASCA) Test Systems. |
| Regulation Medical Specialty | Immunology |
| Review Panel | Immunology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
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| Submission Type | 510(k) |
| CFR Regulation Number | 866.5785 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OKM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |