The FOB Test is a rapid qualitative immunochromatographic test intended for professional in vitro diagnostics. It enables the detection of human hemoglobin in a fecal sample. The test is used to aid in the diagnosis of gastrointestinal bleeding, which may be associated with, among other conditions, diverticulitis, colitis, polyps, and colorectal cancer.

Testing for occult blood in stool can aid in the early detection of abnormalities in the lower gastrointestinal tract. The test is based on an immunochemical method, which allows it to detect human hemoglobin in a stool sample without the need for dietary restrictions prior to testing.

The test provides a result as early as 5 minutes after applying the sample. The result is presented qualitatively—in the form of test lines. The result should not be interpreted after 10 minutes.

This product is intended for professional use. This is a medical device. Use it in accordance with the instructions for use or the label.

Product Features

• Sample type: feces
• Quick and easy test procedure
• Specificity 99.1%, sensitivity 95.3%, accuracy 98.2%
• High-quality product
• Fast results in just 5 minutes!
• Single-use packaging
• Product intended for professional use

Package Contents

• 1 test cassette
• 1 sample collection container with buffer
• 1 user manual

Application

• Rapid diagnosis of occult blood in stool: The test enables the qualitative detection of human hemoglobin in a stool sample, which can aid in the diagnosis of gastrointestinal bleeding.
• Support for the diagnosis of gastrointestinal diseases: The test may be helpful in evaluating bleeding associated with various gastrointestinal disorders, such as diverticulitis, colitis, polyps, or colorectal cancer.
• Screening: The product may be used to support screening for colorectal cancer or gastrointestinal bleeding.
• Bleeding monitoring: The test is recommended for monitoring bleeding in patients and for use as part of routine follow-up examinations.
• Support for medical decision-making: The test result may assist healthcare professionals in making further diagnostic or therapeutic decisions.
• Laboratory use: This product is intended for use by healthcare professionals in laboratories and is not intended for use at the patient’s bedside.

Product identification and responsible entities

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