System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection
The Colorectal Neoplasia DNA Methylation and Hemoglobin Detection System is a qualitative, non-invasive screening device that detects methylation of specific DNA markers associated with colorectal cancer and the presence of occult hemoglobin in specimens including stool, blood, urine, and buccal swabs, intended as an aid in detecting colorectal cancer or advanced adenomas in conjunction with diagnostic colonoscopy. It is an FDA Class 3 device, requiring Pre-Market Approval (PMA), reviewed by the Pathology (PA) panel with no assigned regulation number. The product code is PHP, and the device is indicated for average-risk adults aged 50 and older.
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Basic Information
- Product Code
- PHP
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- PA
- Submission Type
- 2
Device Characteristics
Definition
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.
FEI Numbers
This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.