Avanos Medical Sales LLC #60439 Rapid Test Kit Pytest* 14C-Urea Breath Test Infectious Disease Immunoassay H. Pylori Breath Sample 100 Tests Non-Regulated START UP, PYTEST KIMCLK Features Start-up Package: provides supplies (except capsules and liquid scintillation counter equipment) to perform 100 tests on site The smallest container of Scintillation Fluid available provides a supply to perform 400 tests CLIA does not consider breath to be a specimen; please note that certain states do have their own state regulations - in their state regulations a breath sample may be considered a specimen and therefore regulated under their state licensing procedures Manufacturer # 60439 Brand Pytest* 14C-Urea Breath Test Manufacturer Avanos Medical Sales LLC Country of Origin Unknown Application Rapid Test Kit CLIA Classification Non-Regulated Contents 1 Air Pump, (200) Needles, (100) Collection Vials, Stopwatch, 250 mL Bottle Collection Fluid, (100) Balloons, (100) Straws, 4 Liter Bottle Scintillation Fluid, (100) Patient Brochures, Sample Breath Test Report Form, (400) Medicine Cups, Validation Package: (3)Balloons, (3) Straws, (3) Return Cartons, (3) Patient Result Forms Number of Tests 100 Tests Reading Type Machine Read Sample Type Breath Sample Test Format Balloon Format Test Name H. Pylori Test Type Infectious Disease Immunoassay Time to Results 20 Minute Results UNSPSC Code 41116129PYTEST* START-UP PACKAGE Description The PYtest* Start-Up Package supplies (except capsules and liquid scintillation counter equipment) to perform 100 tests on site. The smallest container of scintillation fluid available provides a supply to perform 400 tests. The test can reach results in less than 20 minutes, enabling quick diagnosis and in-person communication to the patient for the optimal experience. How the PYtest* Start-Up Package Works To begin the test, the patient swallows a PYtest* capsule that contains a small amount of 14C-Urea. If the 14C-Urea comes in contact with H. pylori in the stomach, it is hydrolyzed into 14C-carbon dioxide and ammonia. The carbon dioxide enters the bloodstream and is exhaled by the patient. Ten minutes after ingesting the capsule, a breath sample is collected in a mylar balloon. The breath sample collection balloon may be analyzed on site or sent to Avanos Medical for analysis. The contents of the balloon are transferred into a breath collection fluid, then liquid scintillation fluid is added to complete the solution. The MICROCOUNT* Lite Liquid Scintillation Counter analyzes the breath sample. Compact in size, it provides results in five minutes on an LCD display panel. (A compatible printer or software for outputting results in hard copy is also available.) If the breath sample contains 14C, the patient has H. pylori. If H. pylori is not present, the 14C-Urea is not hydrolyzed and is excreted in the urine.On-site test administration and analysis can be completed in less than 20 minutes. Therefore, test results can be discussed with the patient and treatment prescribed before he or she leaves the office. Available to buy as single units or cases of 10. In addition to the components listed above, the package includes 100 patient brochures, a sample test report form, as well as a validation package consisting of three sets of balloons, straws, return cartons, and patient results forms. Avanos Medical is a leader in Helicobacter pylori (H. pylori) diagnostics. The PYtest* 14C-Urea Breath Test is the first approved 14C-UBT in the U.S. market for the diagnosis of H. pylori. It utilizes 14C-labeled urea in breath samples to identify the presence of the H. pylori bacterium. Read Less Product Features Air pump 200 Needles 100 Collection vials Stopwatch Bottle collection fluid, 250ml 100 Balloons 100 Straws Bottle scintillation fluid, 4 liters 400 Medicine cups
