| Device Type ID | 341 |
| Device Name | Nadh Oxidation/nad Reduction, Ast/sgot |
| Regulation Description | Aspartate Amino Transferase (AST/SGOT) 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 | 862.1100 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | CIT |
| 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 | 341 |
| Device | Nadh Oxidation/nad Reduction, Ast/sgot |
| Product Code | CIT |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Aspartate Amino Transferase (AST/SGOT) Test System. |
| CFR Regulation Number | 862.1100 [🔎] |
| Device Problems | |
|---|---|
Incorrect Or Inadequate Test Results | 6 |
High Test Results | 2 |
Probe | 1 |
Low Test Results | 1 |
| Total Device Problems | 10 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Alfa Wassermann, Inc. | II | Apr-30-2014 |
| 2 | ELITech Clinical Systems SAS | III | Oct-02-2014 |
| 3 | Medtest Holdings, Inc. | III | May-18-2017 |
| 4 | Siemens Healthcare Diagnostics, Inc. | II | May-04-2018 |