| Device Type ID | 283 |
| Device Name | Tetrazolium Int Dye-diaphorase, Lactate Dehydrogenase |
| Regulation Description | Lactate Dehydrogenase 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 | 862.1440 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | CFH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 283 |
| Device | Tetrazolium Int Dye-diaphorase, Lactate Dehydrogenase |
| Product Code | CFH |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Lactate Dehydrogenase Test System. |
| CFR Regulation Number | 862.1440 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 4 |
High Test Results | 3 |
Low Test Results | 3 |
Mechanical Problem | 2 |
Pump | 1 |
Appropriate Term/Code Not Available | 1 |
Holder | 1 |
| Total Device Problems | 15 |