SCK — Ldt, Non-Molecular Antisera For Rare Rbc Antigens When There Is No Alternative Ivd Class N
FDA product code SCK covers "Ldt, Non-Molecular Antisera For Rare Rbc Antigens When There Is No Alternative Ivd", a Class N medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- SCK
- Device Class
- Class N
- Regulation Number
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Unknown
- Implant
- No
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).