| Device Type ID | 2240 |
| Device Name | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control |
| Regulation Description | Fibrinogen/fibrin Degradation Products Assay. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Hematology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 864.7320 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DAP |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 2240 |
| Device | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control |
| Product Code | DAP |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Fibrinogen/fibrin Degradation Products Assay. |
| CFR Regulation Number | 864.7320 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
DIAGNOSTICA STAGO | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
INSTRUMENTATION LABORATORY | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
INSTRUMENTATION LABORATORY CO. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
| Device Problems | |
|---|---|
Low Test Results | 18 |
Unable To Obtain Readings | 14 |
Adverse Event Without Identified Device Or Use Problem | 10 |
False Positive Result | 6 |
High Test Results | 5 |
Incorrect Or Inadequate Test Results | 5 |
False Negative Result | 2 |
Off-Label Use | 1 |
Insufficient Information | 1 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
Device Displays Incorrect Message | 1 |
Test Strip | 1 |
| Total Device Problems | 65 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | BioMerieux SA | II | Aug-14-2014 |
| 2 | Siemens Healthcare Diagnostics Inc | II | Jan-07-2016 |