| Device Type ID | 333 |
| Device Name | Diazo Colorimetry, Bilirubin |
| Regulation Description | Bilirubin (total Or Direct) Test System. |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Clinical Chemistry |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 862.1110 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | CIG |
| 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 | 333 |
| Device | Diazo Colorimetry, Bilirubin |
| Product Code | CIG |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Bilirubin (total Or Direct) Test System. |
| CFR Regulation Number | 862.1110 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ABBOTT | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ABBOTT LABORATORIES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ELITECHGROUP | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Low Test Results | 22 |
High Test Results | 18 |
Incorrect Or Inadequate Test Results | 6 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 2 |
Probe | 1 |
High Readings | 1 |
Device Ingredient Or Reagent | 1 |
| Total Device Problems | 51 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Medtest Holdings, Inc. | II | Jun-14-2017 |
| 2 | Ortho-Clinical Diagnostics | II | Mar-19-2014 |
| 3 | Siemens Healthcare Diagnostics, Inc. | II | May-04-2018 |