| Device Type ID | 2472 |
| Device Name | Reagents, Specific, Analyte |
| Regulation Description | Analyte Specific Reagents. |
| Regulation Medical Specialty | Pathology |
| Review Panel | Hematology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 864.4020 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | MVU |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2472 |
| Device | Reagents, Specific, Analyte |
| Product Code | MVU |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Analyte Specific Reagents. |
| CFR Regulation Number | 864.4020 [🔎] |
| Device Problems | |
|---|---|
Device Damaged Prior To Use | 1 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
False Positive Result | 1 |
| Total Device Problems | 3 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Abbott Molecular | III | Apr-23-2014 |
| 2 | BD Biosciences, Systems & Reagents | II | Apr-02-2015 |
| 3 | BD Biosciences, Systems & Reagents | II | Jan-20-2015 |
| 4 | BD Biosciences, Systems & Reagents | II | May-01-2014 |
| 5 | Becton, Dickinson And Company, BD Biosciences | II | Oct-18-2016 |
| 6 | Becton, Dickinson And Company, BD Biosciences | III | Feb-23-2016 |
| 7 | Becton, Dickinson And Company, BD Biosciences | III | Jan-11-2016 |
| 8 | Becton, Dickinson And Company, BD Biosciences | II | Nov-24-2015 |
| 9 | Becton, Dickinson And Company, BD Biosciences | II | Aug-24-2015 |
| 10 | Cell Marque Corporation | II | Jun-01-2017 |
| 11 | Lab Vision Corporation | II | Jan-16-2014 |