Last synced on 9 May 2025 at 11:05 pm

Docetaxel / Paclitaxel Assay

Page Type
Product Code
Definition
Measures levels of Docetaxel or Paclitaxel in the blood
Physical State
Measures levels of Docetaxel or Paclitaxel in the blood
Technical Method
Measures levels of Docetaxel or Paclitaxel in the blood
Target Area
Blood
Review Panel
Toxicology
Submission Type
Contact ODE
Device Classification
N
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

As product code PRF is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.

Docetaxel / Paclitaxel Assay

Page Type
Product Code
Definition
Measures levels of Docetaxel or Paclitaxel in the blood
Physical State
Measures levels of Docetaxel or Paclitaxel in the blood
Technical Method
Measures levels of Docetaxel or Paclitaxel in the blood
Target Area
Blood
Review Panel
Toxicology
Submission Type
Contact ODE
Device Classification
N
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

As product code PRF is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.