Product code SDM

Device name

Nucleic Acid Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/Ps

Medical specialty

Unknown

Device class

U

Review panel

MI

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

For the qualitative detection of infectious disease agents in human cadaveric (non-heart-beating) specimens

Source

FDA openFDA device classification dataset