Product code QHO

Device name

Nucleic-Acid Tests Used For Infectious Disease Screening Of Blood And Plasma Donations

Medical specialty

Microbiology

Device class

U

Regulation number

610.40

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 nucleic acid for infectious disease agents in human specimens.

Source

FDA openFDA device classification dataset