This study is currently not recruiting participants.

Specimen Acquisition Protocol for DiagCORE? Respiratory Panel

  • STATUS
    Not Recruiting
Updated on 19 February 2024

Summary

This protocol describes the process for acquiring samples that are either residual, de-identified specimens or previously characterized bacterial or viral clinical samples obtained from clinical specimens or retrospective samples that have been stored by the laboratory.

These specimens will be used to support internal development activities and/or analytical studies or clinical evaluations to support applicable filings required the U.S. (FDA) and/or ex-U.S./foreign government regulatory bodies to permit commercial distribution of the DiagCORE? Respiratory Panel.

Description

This protocol describes the process for acquiring samples that are either residual, de-identified specimens or previously characterized bacterial or viral clinical samples obtained from clinical specimens or retrospective samples that have been stored by the laboratory.

These specimens will be used to support internal development activities and/or analytical studies or clinical evaluations to support applicable filings required the U.S. (FDA) and/or ex-U.S./foreign government regulatory bodies to permit commercial distribution of the DiagCORE? Respiratory Panel.

Details
Condition Healthy
Age 100years or below
Clinical Study IdentifierTX8522
Last Modified on19 February 2024

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