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U.S. Department of Health and Human Services

Product Classification
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Device reagents and transportation supplies, sodium citrate blood specimen collection tube
Definition A blood collection tube intended for emergency use in healthcare settings to collect, transport, and store blood specimens for coagulation testing to aid in the identification and treatment of coagulopathy in patients with known or suspected COVID-19.
Physical State Plastic or glass specimen collection device, stabilizing reagents
Technical Method Collection and Maintenance of whole blood clinical specimens
Target Area The device is a venous blood specimen collection device
Review Panel Hematology
Product CodeQPW
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Immunology and Hematology Devices (DIHD)
Not Classified Reason EUA - Emergency Use Authorization
Submission Type EUA - Emergency Use Authorization
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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