| Device Type ID | 3412 |
| Device Name | Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) |
| Regulation Description | Chlamydia Serological Reagents. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.3120 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | LJC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 3412 |
| Device | Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) |
| Product Code | LJC |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Chlamydia Serological Reagents. |
| CFR Regulation Number | 866.3120 [🔎] |
| Device Problems | |
|---|---|
Material Rupture | 1 |
Defective Device | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 3 |