System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection
- US Product Code (FDA)
- PHPView 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 DNA methylation and hemoglobin detection system is a qualitative, non-invasive device used to screen for the detection of methylation of specific DNA markers associated with colorectal cancer and for the presence of occult hemoglobin in human specimens, including stool, blood, urine, and buccal swabs. It is intended as an aid in the detection of colorectal cancer or advanced adenomas in conjunction with diagnostic colonoscopy. It is indicated for use in adults 50 years or older, who are typical average-risk candidates for colorectal cancer (CRC) screening.
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System, Colorectal Neoplasia, Dna Methylation 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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