Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
A Total Prostate Specific Antigen (PSA) Test for Detection of Prostate Cancer is an in vitro diagnostic device that measures both complexed and noncomplexed forms of PSA in serum, used as an aid in the detection and monitoring of prostate cancer. It is classified as FDA Class 3, requiring PMA approval given the clinical significance of the assay in cancer diagnosis, with product code MTF. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- MTF
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- IM
- Submission Type
- 2
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 14 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 14 registration numbers. Click on an entry to view related FDA registrations.