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System, Test, Fibrin/Fibrinogen Degradation Products For Monitoring Of Colorectal Cancer

FDA product code NTY · 1 cleared devices

Class 2 Immunology
Regulation
21 CFR 866.6010
Review panel
IM
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2008-07-01 – 2008-07-01

MONITORING CANCER PATIENTS AFTER THERAPY FOR DISEASE PROGRESSION IN CONJUNCTION WITH OTHER DIAGNOSTIC MODALITIES.

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