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U.S. Department of Health and Human Services

Product Classification
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Device oral fluid drugs of abuse and alcohol test specimen collection device
Regulation Description Blood specimen collection device.
Definition Intended for use in the collection, preservation, and transport of oral fluid specimens for drugs of abuse or alcohol testing.
Physical State Specimen collection device, which may include an absorbent oral fluid collection pad and/or a specimen storage container for collection, preservation and transport.
Technical Method Collects oral fluid and stabilizes it for transport or storage.
Target Area clinical samples (oral fluid)
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodePJD
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Chemistry and Toxicology Devices (DCTD)
Submission Type 510(k)
Regulation Number 862.1675
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 Not Third Party Eligible
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