| Device Type ID | 3036 |
| Device Name | Kit, Test,alpha-fetoprotein For Testicular Cancer |
| Regulation Description | Tumor-associated Antigen Immunological Test System. |
| Regulation Medical Specialty | Immunology |
| Review Panel | Immunology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.6010 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LOJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3036 |
| Device | Kit, Test,alpha-fetoprotein For Testicular Cancer |
| Product Code | LOJ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Tumor-associated Antigen Immunological Test System. |
| CFR Regulation Number | 866.6010 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 18 |
No Apparent Adverse Event | 10 |
High Test Results | 5 |
Low Test Results | 4 |
Incorrect Or Inadequate Test Results | 3 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
Non Reproducible Results | 1 |
| Total Device Problems | 42 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | ORTHO-CLINICAL DIAGNOSTICS | III | Jul-08-2016 |
| 2 | Tosoh Bioscience Inc | II | Jun-05-2018 |