| Device Type ID | 320 |
| Device Name | Radioimmunoassay, Estradiol |
| Regulation Description | Estradiol 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) Exempt |
| CFR Regulation Number | 862.1260 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | CHP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 320 |
| Device | Radioimmunoassay, Estradiol |
| Product Code | CHP |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Estradiol Test System. |
| CFR Regulation Number | 862.1260 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 24 |
High Test Results | 22 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 17 |
Low Test Results | 13 |
Incorrect Or Inadequate Test Results | 7 |
Mechanical Problem | 7 |
No Apparent Adverse Event | 7 |
Calibration Problem | 4 |
Non Reproducible Results | 3 |
Appropriate Term/Code Not Available | 2 |
Insufficient Information | 2 |
Probe | 1 |
Unable To Obtain Readings | 1 |
Device Damaged Prior To Use | 1 |
Cell | 1 |
Mixer | 1 |
Wire | 1 |
Device Operational Issue | 1 |
| Total Device Problems | 115 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Abbott Ireland Diagnostics Division | II | Dec-22-2018 |
| 2 | Abbott Laboratories | II | May-31-2016 |
| 3 | BioMerieux SA | II | Mar-20-2017 |
| 4 | Diasorin Inc. | II | Nov-21-2016 |
| 5 | ORTHO-CLINICAL DIAGNOSTICS | II | Aug-05-2016 |
| 6 | Roche Diagnostics Operations, Inc. | II | Mar-31-2016 |
| 7 | Siemens Healthcare Diagnostics, Inc | II | Feb-04-2018 |
| 8 | Siemens Healthcare Diagnostics, Inc | II | Mar-24-2016 |
| 9 | Siemens Healthcare Diagnostics, Inc. | II | Jul-13-2018 |
| 10 | Siemens Healthcare Diagnostics, Inc. | II | May-05-2017 |
| 11 | Tosoh Bioscience Inc | II | Jun-05-2018 |