510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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SCKNot classified

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

Unknown
FDA source (opens on fda.gov)

SCK is the FDA product code for Ldt, Non-Molecular Antisera For Rare Rbc Antigens When There Is No Alternative Ivd. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
SCK
Device name
Ldt, Non-Molecular Antisera For Rare Rbc Antigens When There Is No Alternative Ivd
FDA 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).
Device class
Not classified
Review panel
Unknown
Submission type
FDA code 7
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code SCK.