Last synced on 9 May 2025 at 11:05 pm

Placental Growth Factor Test

Page Type
Product Code
Definition
For quantitative determination of Placental Growth Factor (PlGF).
Physical State
In Vitro Diagnostic (IVD)
Technical Method
Immunoassay
Target Area
In Vitro Diagnostic (IVD)
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 PZN is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.

Placental Growth Factor Test

Page Type
Product Code
Definition
For quantitative determination of Placental Growth Factor (PlGF).
Physical State
In Vitro Diagnostic (IVD)
Technical Method
Immunoassay
Target Area
In Vitro Diagnostic (IVD)
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 PZN is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.