QGU

Hemoglobin For Donor Testing

Product code
QGU
Device name
Hemoglobin For Donor Testing
Device class
Class 2
21 CFR
21 CFR 864.7500
Medical specialty
Hematology
Marketing pathway
510(K)

FDA classification definition

Assays hemoglobin concentration test for blood donors.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: QGU
Classification and pathway per current FDA publications. Data from openFDA (CC0).