# Ivd Offered As Ldt, First Marketed Before May 6, 2024, Not Modified Beyond Scope Described In Preamble To Ldt Final Rule
> **Product code: SCE** · Not classified · Unknown · —
## Classification
- **FDA Product Code:** SCE
- **Device class:** Not classified
- **Regulation:** —
- **Review panel:** CH
- **Medical specialty:** Unknown
- **Submission type:** 7
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

Currently marketed in vitro diagnostic products (IVDs) offered as laboratory developed tests (LDTs) that were first marketed prior to May 6, 2024, and not modified following that date or not modified beyond the scope described in section V.B.3 of the preamble to the LDT Final Rule (89 FR 37286).

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 0
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=SCE)
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