System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection
- US Product Code (FDA)
- SBBView Product Code Classification →
- US Risk Class (FDA)
- Class 3
- US Regulation (CFR)
- 21 CFRView CFR Regulation →
- Medical specialty
- Unknown
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
The colorectal neoplasia RNA and hemoglobin assay is a non-invasive, qualitative in vitro diagnostic intended for the detection of colorectal neoplasia associated RNA markers and for the presence of occult hemoglobin in human stool. The test is to aid in the detection of colorectal cancer (CRC) and advanced adenomas (AA). The test is not a replacement for diagnostic colonoscopy. It is indicated for use in adults 45 years or older, who are typical average-risk candidates for colorectal cancer (CRC) screening. A positive result may indicate the presence of CRC or AA and should be followed by a diagnostic colonoscopy.
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System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection is a medical device type in the Unknown specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
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