# SCI · Ivd Offered As Ldt, Not An Ldt Or Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

_ ·  · Class N_

**Canonical URL:** https://fda.innolitics.com/productcode/SCI

## 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
- **Regulation:** 21 CFR N/A
- **Device Class:** N
- **Review Panel:** [](/submissions/)

## 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._

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**Source:** [https://fda.innolitics.com/productcode/SCI](https://fda.innolitics.com/productcode/SCI)

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