FDA device listing
Invitae Saliva Collection kit
FDA device listing 1779883657 · Labcorp Genetics
Key facts
| Proprietary names | Invitae Saliva Collection kit |
|---|---|
| Owner/operator | Labcorp Genetics |
| Owner/operator number | 10087208 |
| Premarket submissions | K152556 |
| Product codes | OYJ |
| Device names | OYJ - Dna Specimen Collection, Saliva |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.1675 |
| Review panels | Clinical Chemistry |
| Registered establishments | Labcorp Genetics |
| Establishment registrations | 3013248161 |
| FEI numbers | 3013248161 |
| Establishment operations | Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database