| Device Type ID | 690 |
| Device Name | Radioimmunoassay (two-site Solid Phase), Ferritin |
| Regulation Description | Ferritin Immunological Test System. |
| Regulation Medical Specialty | Immunology |
| Review Panel | Clinical Chemistry |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.5340 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | JMG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 690 |
| Device | Radioimmunoassay (two-site Solid Phase), Ferritin |
| Product Code | JMG |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Ferritin Immunological Test System. |
| CFR Regulation Number | 866.5340 [🔎] |
| Device Problems | |
|---|---|
Low Test Results | 15 |
High Test Results | 4 |
Mechanical Problem | 3 |
Tube | 2 |
Incorrect Or Inadequate Test Results | 1 |
Missing Value Reason | 1 |
Probe | 1 |
Labelling, Instructions For Use Or Training Problem | 1 |
Non Reproducible Results | 1 |
Seal | 1 |
Valve | 1 |
PC (Printed Circuit) Board | 1 |
Cups | 1 |
Device Operates Differently Than Expected | 1 |
| Total Device Problems | 34 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Beckman Coulter Inc. | II | Apr-17-2017 |
| 2 | Siemens Healthcare Diagnostics, Inc. | II | Aug-15-2014 |