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U.S. Department of Health and Human Services

Product Classification
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Device ldt, not under a targeted enforcement discretion policy described in preamble to ldt final rule
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).
Physical State In vitro diagnostic device
Technical Method In vitro diagnostic device
Target Area In vitro diagnostic device
Review Panel Clinical Chemistry
Product CodeSCJ
Premarket Review Division of Chemistry and Toxicology Devices (DCTD)
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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