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Sirolimus Test System

FDA product code NRP · 4 cleared devices

Class 2 Clinical Toxicology
Regulation
21 CFR 862.3840
Review panel
TX
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2005-04-07 – 2009-03-30

Sirolimus test systems are intended for the quantitative measurement of sirolimus in whole blood as an aid in management of transplant patients taking this sirolimus.

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