FDA product code SCF: Ldt, Unmet Need Within An Integrated Healthcare System
SCF is the FDA product code for ldt, unmet need within an integrated healthcare system. It is a Not classified device, reviewed by the Clinical Chemistry panel. Devices under SCF reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
Laboratory developed tests (LDTs) manufactured and performed by a laboratory integrated within a healthcare system to meet an unmet need of patients receiving care within the same healthcare system as described in section V.B.3 of the preamble to the LDT Final Rule (89 FR 37286).
Classification
| Field | Value |
|---|---|
| Device name | Ldt, Unmet Need Within An Integrated Healthcare System |
| Device class | Not classified |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Unknown |
| Premarket route | 510(k) exempt |
Recalls for SCF devices
openFDA lists no recalls for product code SCF.
Frequently asked questions
What is FDA product code SCF?
SCF is the FDA product code for ldt, unmet need within an integrated healthcare system. It is a Not classified device, reviewed by the Clinical Chemistry panel.
What device class is SCF?
Not classified. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code SCF
- Run a recall and safety report across every SCF manufacturer
- Watch product code SCF 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.
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