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U.S. Department of Health and Human Services

Product Classification
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Device dna specimen collection, saliva
Regulation Description Blood specimen collection device.
Definition A collection device intended for use in the non-invasive collection of saliva samples for clinical dna testing.
Physical State specimen collection device
Technical Method Collects DNA in saliva and stabilizes it for transport or storage
Target Area clinical samples (saliva)
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodeOYJ
Premarket Review Division of Chemistry and Toxicology Devices (DCTD)
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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