510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QYTClass II

Over-The-Counter Covid-19 Antigen Test

21 CFR 866.3984 / Microbiology
FDA source (opens on fda.gov)

QYT is the FDA product code for Over-The-Counter Covid-19 Antigen Test, a class II device type, regulated under 21 CFR 866.3984. FDA's definition for this code reads: "For the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen in individuals 2 years and older". As of , FDA records hold 14 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
QYT
Device name
Over-The-Counter Covid-19 Antigen Test
FDA definition
For the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen in individuals 2 years and older.
Regulation
21 CFR 866.3984
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
14
Ingested recalls
3

Clearances, product code QYT

By decision year
14 clearances under product code QYT with a decision year between 2023 and 2026, 2024 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code QYT by decision year
YearClearances
20231
20245
20255
20263

Applicants with the most clearances

Product code QYT
Applicants holding the most 510(k) clearances under product code QYT
ApplicantClearances
Acon Laboratories, Inc.2
Abbott Diagnostics Scarborough, Inc.1
Access Bio, Inc.1
Assure Tech LLC1
CorDx, Inc.1
Genabio Diagnostics Inc1
Genbody.Inc.1
Guangzhou Wondfo Biotech Co., Ltd.1
Healgen Scientific LLC1
iHealth Labs, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 21 companies shown, in name order