QHTUnclassified

Reagent Red Blood Cells

21 CFR 660.30 / Hematology

QHT is the FDA product code for Reagent Red Blood Cells, regulated under 21 CFR 660.30. FDA's definition for this code reads: "For the detection of or identification of human blood-group antibodies". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: QHT
Device name: Reagent Red Blood Cells
FDA definition: For the detection of or identification of human blood-group antibodies
Regulation: 21 CFR 660.30
Device class: Unclassified
Review panel: Hematology
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

No registered establishment in MDM’s records lists product code QHT.

Recent clearances

Product code QHT

FDA records hold no clearances under product code QHT.

Recent recalls

Product code QHT

FDA records show no recalls under product code QHT.

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)