| Device Type ID | 3038 |
| Device Name | Anti-dna Antibody, Antigen And Control |
| Regulation Description | Antinuclear Antibody 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 | 866.5100 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LSW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 3038 |
| Device | Anti-dna Antibody, Antigen And Control |
| Product Code | LSW |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Antinuclear Antibody Immunological Test System. |
| CFR Regulation Number | 866.5100 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
INOVA DIAGNOSTICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 16 |
Impedance Problem | 2 |
Premature Elective Replacement Indicator | 1 |
Application Program Freezes, Becomes Nonfunctional | 1 |
High Impedance | 1 |
Use Of Device Problem | 1 |
Fracture | 1 |
| Total Device Problems | 23 |