SCI · Ivd Offered As Ldt, Not An Ldt Or Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule
· Class N
Overview
| Product Code | SCI |
|---|---|
| Device Name | Ivd Offered As Ldt, Not An Ldt Or Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule |
| Device Class | Class N |
| Review Panel |
Identification
In vitro diagnostic products (IVDs) offered as laboratory developed tests (LDTs) that are not designed, manufactured, and used within a single laboratory, are within the scope of the phaseout policy and are not subject to a targeted enforcement discretion policy described in the preamble to the LDT Final Rule (89 FR 37286).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
