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U.S. Department of Health and Human Services

Product Classification
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Device ivd offered as ldt, not an ldt or under a targeted enforcement discretion policy described in preamble to ldt final rule
Definition In vitro diagnostic products (IVDs) offered as laboratory developed tests (LDTs) that are not designed, manufactured, and used within a single laboratory, are within the scope of the phaseout policy and are not subject to a targeted enforcement discretion policy described in the preamble to the LDT Final Rule (89 FR 37286).
Physical State In vitro diagnostic device
Technical Method In vitro diagnostic device
Target Area In vitro diagnostic device
Review Panel Clinical Chemistry
Product CodeSCI
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Chemistry and Toxicology Devices (DCTD)
Not Classified Reason Enforcement Discretion
Submission Type Enforcement Discretion
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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