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