the Rapid Latex Agglutination Assay laboratories medical clinics physician's offices payday loans emergency care situations blood banks In December 1994

Two PMAs for home blood sample collection kits labeled as part of a HIV testing system In recent years

As may be the case with new technologies As advances are made The FDA uses non-mandatory language such as should may Product License Applications (PLAs) Establishment License Applications (ELAs) 600-680 PLA/ELA

BLA or IDE/PMA) the intended use

the labeling claims if available The sponsor should provide in the application assay optimization amplification guanidine:cytosine (GC) ratio target sequence

amplification detection

quantitation and instrumentation for these processes The length region specificity and efficiency of primer and/or capture sequence; Methods of extraction amplification

hybridization detection

and quantitation; - for a multiplex format);

During this phase of assay optimization For qualitative assays the assay cutoff or reporting threshold For quantitative assays If the assay is quantitative cells plasma whole blood

The composition of the buffers reagents

storage amplification hybridization detection For pool testing Information on size GC content melting temperatures hairpin or other secondary structures if any electrophoresis or ion exchange HPLC)

hybridization If reagents are obtained from vendors The identity purity potency For enzymes obtained from vendors In addition therefore