5) Nonstandard abbreviations: A[beta], [beta]-amyloid; CSF, cerebrospinal fluid; APP, amyloid precursor protein; t-tau, total tau; p-tau, phosphorylated tau; PET, positron emission tomography; PiB, Pittsburgh compound B; ADNI, AD Neuroimaging Initiative; IVD, in vitro diagnostic; RUO
, research use only; CRM, certified reference material; RMP, reference measurement procedure; BACE, [beta]-secretase.
227 for TUO and RUO
respectively with coefficient of determination ([R.
Lastly, bioMeerieux developed the VITEK MS Plus system that includes use of the FDA-cleared database in conjunction with the more comprehensive VITEK MS RUO
software and database.
In November 1994, a plasma donation was destroyed after the serum tested positive by combination HIV-1/HIV-2 EIA and RUO
assay will cover a breadth of cancer types by analysing over 100 cancer-related genes that are included in professional society guidelines, linked to targeted therapies currently in clinical trials, or part of well-documented cancer pathways, according to the companies.
Ashwood: Yes, the draft guidance for industry and FDA staff issued by CDRH/OIVD (Center for Devices and Radiological Health/Office of In Vitro Diagnostic Device Evaluation and Safety) on June 1, 2011 (issued for comment purposes only), created a reluctance of some vendors to sell RUO
products to clinical laboratories.
The company's product categories include Clinical IVD Products, RUO
Products and Product Pipeline.
Therefore, an IVD manufacturer might it very tempting to avoid the trouble and expense of a 510(k) or premarket-approval submission by labeling a product as RUO
or IUO, despite knowing full well that the product is likely being used as an IVD under conditions in which there is no research protocol and no oversight by an institutional review board.
Evaluation of the Abbott realtime HCV genotype II RUO
(GT II) assay with reference to 5'UTR, core and NS5B sequencing.
Amarantus anticipates launching LymPro for RUO
in the fourth quarter of 2014, primarily targeting pharmaceutical clinical studies.
Contract award notice: This open procedure has for object the maintenance of the park application RAI - divided for application ICT - RUO
Samples from over 100 cases of primary prostate and colon cancer have demonstrated 100% concordance for PTEN loss among SP218 and the existing PTEN RUO