Webmated (Polymedco OC-Sensor DIANA iFOB test and Polymedco OC Auto Micro 80) and not CLIA-waived tests, and the others are manual, CLIA-waived tests. Several studies … WebPolymedco OC-Light FOB Test 2. Predicate 510(k) number(s): K041297 3. Comparison with predicate: Similarities Item Device OC-Light S FIT, K143325 Predicate Polymedco …
OC-LighLightt Ò Manual iFOBT Kit - VWR
Webresults. Repeat the test or call Polymedco Technical Services at 800-431-2123. LIMITATIONS · The OC-Light iFOB Test is intended only for the detection of hemoglobin in feces. It is not advised for use in patients suspected of upper GI bleeding. · Patients with the following conditions should not be considered for testing as these conditions WebMar 27, 2014 · In a secondary analysis of data from 9989 patients with available Cologuard, PolyMedco FIT, and histology results, CRC sensitivity was 92.3% (60/65) for Cologuard and 73.8% (48/65) for PolyMedco ... the nutshell lake huntington ny
182949: Occult Blood, Fecal, Immunoassay Labcorp
WebFecal Immunochemical Test Package Insert >>download here<<. FIT Package Insert Version 3.0 update 10/2015. This two sided document is the CLIA Waived/OTC cleared document which explains the collection method in pictorial form (ENGLISH) on one side, and the long format instructions for collection and resulting the test on the opposite side. WebPolymedco OC Light FOB Test and the expected results was 97.3% (95% CI 93.1 ∼ 99.3%) Cut off study The cut-off value of OC-Light S FIT was established as 10 µg hemoglobin/g stool (50 ng/mL buffer). No significant difference was observed between the results of OC-Light S FIT and the predicate Polymedco OC Light FOB Test. WebGet FIT. Contact Polymedco CDP, LLC. Colon cancer is preventable if detected early. Don't wait for symptoms to occur because often there are no symptoms. Get the FIT test - a simple and affordable, at home screening kit. Contact Polymedco CDP, LLC at 888 638 7757 or email at [email protected]. michigan sour cherries