# Ldt, Non-Molecular Antisera For Rare Rbc Antigens When There Is No Alternative Ivd
> **Product code: SCK** · Not classified · Unknown · —
## Classification
- **FDA Product Code:** SCK
- **Device class:** Not classified
- **Regulation:** —
- **Review panel:** HE
- **Medical specialty:** Unknown
- **Submission type:** 7
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

Non-molecular antisera laboratory developed tests (LDTs) for rare red blood cell (RBC) antigens when manufactured and performed by blood establishments, including transfusion services and immunohematology laboratories, and when there is no alternative in vitro diagnostic product (IVD) available to meet the patient's need for a compatible blood transfusion within the scope described in Section V.B.3 of the preamble to the Final LDT 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=SCK)
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