SCF · Ldt, Unmet Need Within An Integrated Healthcare System
· Class N
Overview
| Product Code | SCF |
|---|---|
| Device Name | Ldt, Unmet Need Within An Integrated Healthcare System |
| Device Class | Class N |
| Review Panel |
Identification
Laboratory developed tests (LDTs) manufactured and performed by a laboratory integrated within a healthcare system to meet an unmet need of patients receiving care within the same healthcare system as described in section V.B.3 of the preamble to the LDT Final Rule (89 FR 37286).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
