(156 days)
Stat-Simple™ pylori is a colloidal-gold based immunoassay for use in the qualitative detection of circulating IgG antibody to Helicobacter pylori in human whole blood or serum. The blood specimen is obtained by fingerstick using a lancet designed for that purpose. This test is intended for use in the clinical laboratory or the physician's office. It is intended for use as an aid to diagnosis of H. pylori infection in persons with gastrointestinal symptoms consistent with diseases related to H. pylori infection (1). FOR IN VITRO DIAGNOSTIC USE.
Stat-Simple™ pylori is a colloidal-gold based immunoassay.
This document is a marketing authorization letter for the device "Stat-Simple Pylori" and an "Indications For Use" statement. It does not contain information about acceptance criteria, device performance, sample sizes, ground truth establishment, or study designs as requested. Therefore, I cannot fulfill your request with the provided text.
§ 866.3110
Campylobacter fetus serological reagents.(a)
Identification. Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identifyCampylobacter fetus from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium and provides epidemiological information on these diseases.Campylobacter fetus is a frequent cause of abortion in sheep and cattle and is sometimes responsible for endocarditis (inflammation of certain membranes of the heart) and enteritis (inflammation of the intestines) in humans.(b)
Classification. Class I (general controls).