Definition: A Collection Device Intended For Use In The Non-invasive Collection Of Saliva Samples For Clinical Dna Testing.
| Device Type ID | 651 |
| Device Name | Dna Specimen Collection, Saliva |
| Physical State | Specimen Collection Device |
| Technical Method | Collects DNA In Saliva And Stabilizes It For Transport Or Storage |
| Target Area | Clinical Samples (saliva) |
| Regulation Description | Blood Specimen Collection Device. |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Clinical Chemistry |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 862.1675 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OYJ |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 651 |
| Device | Dna Specimen Collection, Saliva |
| Product Code | OYJ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Blood Specimen Collection Device. |
| CFR Regulation Number | 862.1675 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
DNA GENOTEK INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DNA GENOTEK, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |