| Device Type ID | 2913 |
| Device Name | Ferritin, Antigen, Antiserum, Control |
| Regulation Description | Ferritin 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 | 866.5340 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DBF |
| 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 | 2913 |
| Device | Ferritin, Antigen, Antiserum, Control |
| Product Code | DBF |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Ferritin Immunological Test System. |
| CFR Regulation Number | 866.5340 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
DIAZYME LABORATORIES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SIEMENS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SIEMENS HEALTHCARE DIAGNOSTICS INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Unable To Obtain Readings | 6 |
Device Damaged Prior To Use | 6 |
High Test Results | 3 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Mechanical Problem | 1 |
Low Test Results | 1 |
| Total Device Problems | 18 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Siemens Healthcare Diagnostics, Inc | II | Oct-24-2014 |
| 2 | Siemens Healthcare Diagnostics, Inc. | II | May-05-2017 |
| 3 | Tosoh Bioscience Inc | II | Jun-05-2018 |