

# SCF · Ldt, Unmet Need Within An Integrated Healthcare System

_ ·  · Class N_

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

## Overview

- **Product Code:** SCF
- **Device Name:** Ldt, Unmet Need Within An Integrated Healthcare System
- **Regulation:** 21 CFR N/A
- **Device Class:** N
- **Review Panel:** [](/submissions/)

## 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._

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

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