← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · UNCLASSIFIED

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

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).

DEVICE CLASS
Unclassified
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
HE
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
0
510(K)/PMA CLEARANCES
0
RECALL ENTRIES

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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