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U.S. Department of Health and Human Services

Product Classification

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Device meprobamate test system
Regulation Description Meprobamate test system.
Definition A meprobamate test system is a device intended to measure meprobamate in human specimens. Measurements obtained by this device are used to detect the presence of meprobamate to diagnose the use or overdose of meprobamate or structurally-related drug compounds (e.g., prodrugs).
Physical State Enzyme immunoassay reagent kit
Technical Method Enzyme immunoassay
Target Area Human specimens, urine
Regulation Medical Specialty Toxicology
Review Panel Toxicology
Product CodeQBK
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 862.3590
Device Class 2
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
Accredited Persons
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