QHMUnclassified

Serology Tests Used For Infectious Disease Screening Of Blood And Plasma Donations

21 CFR 610.40 / Microbiology

QHM is the FDA product code for Serology Tests Used For Infectious Disease Screening Of Blood And Plasma Donations, regulated under 21 CFR 610.40. FDA's definition for this code reads: "For the qualitative detection of antibodies or antigens to infectious disease agents in human specimens". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: QHM
Device name: Serology Tests Used For Infectious Disease Screening Of Blood And Plasma Donations
FDA definition: For the qualitative detection of antibodies or antigens to infectious disease agents in human specimens
Regulation: 21 CFR 610.40
Device class: Unclassified
Review panel: Microbiology
Submission type: Contact ODE
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

Abbott Medical

Recent clearances

Product code QHM

FDA records hold no clearances under product code QHM.

Recent recalls

Product code QHM

FDA records show no recalls under product code QHM.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)