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U.S. Department of Health and Human Services

Product Classification
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Device blood/plasma collection device for dna testing
Regulation Description Blood specimen collection device.
Definition A blood collection device for DNA testing is an in vitro diagnostics device intended to collect and transport blood specimens to the laboratory for clinical DNA testing.
Physical State Blood collection device
Technical Method The blood is drawn in the tube to be transported to the laboratory for clinical DNA testing.
Target Area Whole blood/ plasma for in vitro diagnostics
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodePJE
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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