Definition: A General Purpose Reagent Is A Chemical Reagent That Has General Laboratory Application, That Is Used To Collect, Prepare, And Examine Specimens From The Human Body For Diagnostic Purposes, And That Is Not Labeled Or Otherwise Intended For A Specific
| Device Type ID | 5027 |
| Device Name | General Purpose Reagent |
| Physical State | N/A |
| Technical Method | N/A |
| Target Area | Diagnostic |
| Regulation Description | General Purpose Reagent. |
| Regulation Medical Specialty | Pathology |
| Review Panel | Pathology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 864.4010 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | PPM |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5027 |
| Device | General Purpose Reagent |
| Product Code | PPM |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | General Purpose Reagent. |
| CFR Regulation Number | 864.4010 [🔎] |
| Device Problems | |
|---|---|
Incorrect Or Inadequate Test Results | 4 |
Fluid Leak | 1 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
Device Component Or Accessory | 1 |
Shipping Damage Or Problem | 1 |
| Total Device Problems | 9 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Becton Dickinson & Co. | III | Apr-28-2018 |
| 2 | BioMerieux SA | II | Oct-23-2018 |
| 3 | BioMerieux SA | II | Nov-09-2017 |
| 4 | BioMerieux SA | II | Mar-19-2017 |
| 5 | BioMerieux SA | I | Jan-13-2017 |
| 6 | Ventana Medical Systems Inc | I | Sep-14-2018 |
| 7 | Ventana Medical Systems Inc | I | Feb-27-2018 |
| 8 | bioMerieux, Inc. | II | Nov-09-2018 |