For the learners of English, Santo's and Andrea's productions share characteristics of NUO and IUO at the beginning of data collection.
In achieving IUO, the learners regularly develop three main phrasal patterns, expanding (a) to (A), (B), and (c) to (C) as follows:
The ViroSeq system used for the IDE clinical trial will be appropriately labeled: "For Investigational Use Only (IUO
These include such compounds as Analyte Specific Reagents (ASR) and Research Use Only (RUO) and Investigational Use Only (IUO
On June 1, 2011, the US Food and Drug Administration (FDA) Office of In Vitro Diagnostic Device Evaluation and Safety issued draft guidance for industry and FDA staff intended to provide guidance regarding the FDA's thinking about in vitro diagnostic device (IVD) products labeled for "Research Use Only" (RUO) or "Investigational Use Only" (IUO) (1).
Nevertheless, the laboratory community is right to be concerned about the guidance document statement that manufacturers should not sell RUO or IUO reagents "to laboratories that they know use the product for clinical diagnostics use." This statement could have unintended consequences that adversely affect patient care.
Investigational use only (IUO).--A product being shipped or delivered for product testing before full commercial marketing (for example, for use on specimens derived from humans to compare the usefulness of the product with other products or procedures that are in current use or recognized as useful) (21CFR809.10).
An LDT may or may not use analyte-specific reagent, RUO, or IUOs; the type of reagents and devices used does not affect whether a test is classified as an LDT.
land sand sans seas | know this: "IUO
" [high crash except key-eye]
To address these issues, we evaluated and measured an investigational-use-only high-sensitivity cardiac troponin I assay (hs-cTnI IUO) in a high-risk stable CVD population: the Heart Outcomes Prevention Evaluation (HOPE) study.
The Beckman Coulter hs-cTnI IUO assay used in this study (reagent lot 915790, calibrator lot 915791) has undergone modifications compared with the hs-cTnI prototype assay, similar to what has been done to their commercial assay (28).