Definition: The Qualitative Detection Of Measles Specific IgG Antibodies In Serum Or Plasma.
| Device Type ID | 3411 |
| Device Name | Enzyme Linked Immunoabsorbent Assay, Rubeola Igg |
| Physical State | IVD Reagent Kit |
| Technical Method | Antigens And Antisera Used For The Detection Of Measles Antibodies |
| Target Area | Not Applicable In Vitro Use |
| Regulation Description | Rubeola (measles) Virus Serological Reagents. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 866.3520 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | LJB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3411 |
| Device | Enzyme Linked Immunoabsorbent Assay, Rubeola Igg |
| Product Code | LJB |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Rubeola (measles) Virus Serological Reagents. |
| CFR Regulation Number | 866.3520 [🔎] |
| Device Problems | |
|---|---|
Incorrect, Inadequate Or Imprecise Result Or Readings | 4 |
False Negative Result | 3 |
False Positive Result | 2 |
Fluid Leak | 1 |
Device Damaged Prior To Use | 1 |
| Total Device Problems | 11 |