MZFClass II

Test, Hiv Detection

21 CFR 866.3956 / Microbiology

MZF is the FDA product code for Test, Hiv Detection, a class II device type, regulated under 21 CFR 866.3956. As of 2026-09-10, FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code: MZF
Device name: Test, Hiv Detection
Regulation: 21 CFR 866.3956
Device class: Class II
Review panel: Microbiology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 28 companies shown, in name order

Recent clearances

Product code MZF

FDA records hold no clearances under product code MZF.

Recent recalls

Product code MZF

Z-1845-2025Class IItransit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the...Mckesson Medical-Surgical Inc. Corporate Office / initiated 2025-04-24 / 1 unit

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)