MKAClass I

Kit, Direct Antigen, Negative Control

21 CFR 862.1660 / Clinical Chemistry

MKA is the FDA product code for Kit, Direct Antigen, Negative Control, a class I device type, regulated under 21 CFR 862.1660. As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: MKA
Device name: Kit, Direct Antigen, Negative Control
Regulation: 21 CFR 862.1660
Device class: Class I
Review panel: Clinical Chemistry
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

Healgen Scientific LLC

Recent clearances

Product code MKA

FDA records hold no clearances under product code MKA.

Recent recalls

Product code MKA

FDA records show no recalls under product code MKA.

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)