SCK

Ldt, Non-Molecular Antisera For Rare Rbc Antigens When There Is No Alternative Ivd

Product code

SCK

Device name

Ldt, Non-Molecular Antisera For Rare Rbc Antigens When There Is No Alternative Ivd

Device class

Class N

Medical specialty

Unknown

Marketing pathway

Enforcement Discretion

FDA classification 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).

Definition text from the FDA device classification database (U.S. federal government work, public domain).