Definition: The Test System Is Intended For The Qualitative Determination Of IgG Class Autoantibodies Against Phospholipase A2 Receptor (PLA2R) In Human Serum. It Is Used As An Aid In The Diagnosis Of Primary Membranous Glomerulonephritis (pMGN), In Conjunction
| Device Type ID | 3114 |
| Device Name | Anti-phospholipase A2 Receptor |
| Physical State | Slides Coated With Cells, Fluorescein-labelled Detection Antibody, Positive And Negative Controls, Buffers, Embedding Medium, Cover Glasses |
| Technical Method | Indirect Immunofluorescence Assay (IFA) |
| Target Area | Serum |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Immunology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.5780 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PGV |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3114 |
| Device | Anti-phospholipase A2 Receptor |
| Product Code | PGV |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 866.5780 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
EUROIMMUN US | ||
GRANTED | 1 | |
EUROIMMUN US INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |