| Device Type ID | 2963 |
| Device Name | Igg, Antigen, Antiserum, Control |
| Regulation Description | Immunoglobulins A, G, M, D, And E 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 | 866.5510 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DEW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 2963 |
| Device | Igg, Antigen, Antiserum, Control |
| Product Code | DEW |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Immunoglobulins A, G, M, D, And E Immunological Test System. |
| CFR Regulation Number | 866.5510 [🔎] |
| Device Problems | |
|---|---|
Incorrect Or Inadequate Test Results | 12 |
Low Test Results | 5 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 3 |
Complete Blockage | 1 |
False Negative Result | 1 |
Pumping Problem | 1 |
Device Reprocessing Problem | 1 |
Device Operates Differently Than Expected | 1 |
Occlusion Within Device | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Seal | 1 |
| Total Device Problems | 28 |