FOB Fecal Occult Home Blood Test, Single Cassette, FDA and CLIA waived

Description

This is for 1 individual Home Test.  Entire box is not included.
Now CLIA Waived! K Number in CLIA Database is K063673.
A Fecal Occult Blood test is done to detect invisible traces of blood within the stool.
Description:
Blood in the stool is usually an indicator of gastrointestinal problems such as inflammatory intestinal infections, hemorrhoids, anal fissures (cracks in the skin of the rectum that bleed), peptic ulcers, Crohn’s disease, diverticulitis, acid reflux disease, and ulcerative colitis.
It can also be an indicator of colon or rectal cancers.
Medical guidelines state that everyone should have a fecal occult blood test each and every year starting at age 50
Test includes FOB Test Cassette and Collection Tube
Test Immune specific (recognize specifically) for Human Hemoglobin
Fecal Occult Blood Test is FDA Approved for Home Use
CLIA Waived and Reimbursable by Medical Insurance Company
FOB Test Results in Just 5 Minutes
Instructions:
Collect a random sample of feces in a clean, dry receptacle
Unscrew the top of the collection tube and remove the applicator stick.
Insert the stick into the fecal specimen at several different sites.
Remove excess sample from the stick by gently wiping with an absorbent tissue.
Replace the stick in the tube and tighten securely
Shake the tube vigorously to ensure a good liquid suspension then holding the tube upright, snap off the tip.
Dispense four drops of solution into the cassette well.
Read the results within 5 minutes after adding the extraction solution
NOTE: In order to prevent any incorrect results, the test results should not be interpreted after 10 minutes.
Results:
Positive:
Two rose-pink color bands appear: one in the test zone ("T") and one in the control zone ("C"). A positive result indicates that the specimen contains human hemoglobin.
Negative:
One rose-pink color band appears in the control zone ("C"), with no band in the test zone ("T"). A negative result indicates that the specimen does not contain a detectable level of human hemoglobin.
Invalid:
No rose-pink color band appears in the control zone ("C"), or a band appears in the test zone ("T") but not in the control zone. An invalid result may be due to improper testing procedure or deterioration of the reagents. Repeat the test using a new device.
Note:  There is no meaning attributed to the line color intensity or width. Any evidence of a line should be considered a line
Additional Information:
The analytical sensitivity of the test is 0.05 μg hHb/ml buffer. The Fecal Occult Blood Test is designed to detect lower levels of fecal occult blood than standard guaiac tests. The basis of the test is an immunochro-matographic sandwich capture method which yields results more specific to human hemoglobin and are easier to interpret than those of guaiac based devices. In addition, unlike guaiac assays, the accuracy of the Fecal Occult Blood Test is not affected by interfering substances and does not require any specific dietary restrictions for the collection of sample specimen. One step cassette style fecal occult blood test is a simple form of examination.
This is a simple, straight binding immunoassay for the quick and qualitative detection of human occult blood in feces. The assay is invented to identify the lower stages of colorectal bleeding than other biochemical detection methods. The test code is an immunochro-matographic sandwich technique using two specific monoclonal antibodies to purposively identify hemoglobin in test samples.
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On Jan-18-18 at 14:54:34 PST, seller added the following information: