FDA product code SCK: Ldt, Non-Molecular Antisera For Rare Rbc Antigens When There Is No Alternative Ivd
SCK is the FDA product code for ldt, non-molecular antisera for rare rbc antigens when there is no alternative ivd. It is a Not classified device, reviewed by the Hematology panel. Devices under SCK reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
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).
Classification
| Field | Value |
|---|---|
| Device name | Ldt, Non-Molecular Antisera For Rare Rbc Antigens When There Is No Alternative Ivd |
| Device class | Not classified |
| Review panel | HE — Hematology |
| Medical specialty | Unknown |
| Premarket route | 510(k) exempt |
Recalls for SCK devices
openFDA lists no recalls for product code SCK.
Frequently asked questions
What is FDA product code SCK?
SCK is the FDA product code for ldt, non-molecular antisera for rare rbc antigens when there is no alternative ivd. It is a Not classified device, reviewed by the Hematology panel.
What device class is SCK?
Not classified. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code SCK
- Run a recall and safety report across every SCK manufacturer
- Watch product code SCK for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.