FDA product code SCJ

Ldt, Not Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

Unknown·Class N·21 CFR
US regulatory classifications
US Product Code (FDA)
SCJ
View Product Code Classification →
US Risk Class (FDA)
Class N
US Regulation (CFR)
21 CFR
View CFR Regulation →
Medical specialty
Unknown
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

Laboratory developed tests (LDTs) within the scope of the phaseout policy and not subject to a targeted enforcement discretion policy described in section V.B of the preamble to the LDT Final Rule (89 FR 37286).

Search keywords
About this record

Ldt, Not Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule is a medical device type in the Unknown specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.