KQFClass II

Assay, Glutathione Reductase

21 CFR 864.7375 / Hematology

KQF is the FDA product code for Assay, Glutathione Reductase, a class II device type, regulated under 21 CFR 864.7375. As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: KQF
Device name: Assay, Glutathione Reductase
Regulation: 21 CFR 864.7375
Device class: Class II
Review panel: Hematology
Submission type: 510(k) exempt
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

Randox Laboratories, Limited

Recent clearances

Product code KQF

FDA records hold no clearances under product code KQF.

Recent recalls

Product code KQF

FDA records show no recalls under product code KQF.

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)