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U.S. Department of Health and Human Services

Product Classification

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Device data acquisition software
Regulation Description Instrumentation for clinical multiplex test systems.
Definition Software that integrates a network of sample pooling instruments, and manages the overall blood analysis sample workflow.Software acquires and processes data from various donor screening, diagnostic, multiplex assay instruments.
Physical State Standalone software running on a PC or on a mobile platform.
Technical Method Software accesses various instruments either wirelessly or wired through the communication protocol defined by these instruments. Software retrieves data stored in these instruments and creates a workflow repository of the samples tested.
Target Area Systemic viral infection
Regulation Medical Specialty Clinical Chemistry
Review Panel Microbiology
Product CodePQQ
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 862.2570
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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